Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT00802503
Status:
COMPLETED
Last Update Posted:
2013-04-19
First Post:
2008-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'claudia-paula.heidegger@hcuge.ch', 'phone': '+41223827440', 'title': 'Dr CP Heidegger', 'organization': 'Geneva University Hospitals, Division of Intensive Care,Rue Gabrielle Perret Gentil 4, CH-1211 Geneva 14/Switzerland'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The trial was limited by the fact that it was not double blinded by design. However, the risk of bias was reduced because the investigators worked independently from the physicians in charge of the patients.'}}, 'adverseEventsModule': {'timeFrame': 'The follow up period was until day 28.', 'description': 'No adverse events were observed during the intervention period from day 4 to day 8.', 'eventGroups': [{'id': 'EG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.', 'otherNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.', 'otherNumAtRisk': 153, 'otherNumAffected': 0, 'seriousNumAtRisk': 153, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Documented Infection Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20 days', 'description': 'Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28', 'unitOfMeasure': 'Infections', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hours on Mechanical Ventilation in All Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000', 'lowerLimit': '138', 'upperLimit': '189'}, {'value': '153', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '178'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Mechanical ventilation hours during study duration (days 1-28)', 'unitOfMeasure': 'hours of mechanical ventilation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}, {'type': 'SECONDARY', 'title': 'Antibiotic Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '13'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '15'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 days', 'description': 'Number of days between day 9 to day 28 (follow-up period) free of antibiotics', 'unitOfMeasure': 'number of days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}, {'type': 'SECONDARY', 'title': 'Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '27', 'groupId': 'OG000'}, {'value': '103', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.', 'unitOfMeasure': '% of energy target', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}, {'type': 'SECONDARY', 'title': 'General Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '18', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '20', 'spread': '13', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '19'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}, {'type': 'SECONDARY', 'title': 'Days in ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '14'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '14'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Days in ICU', 'unitOfMeasure': 'days in ICU', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}, {'type': 'SECONDARY', 'title': 'ICU Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '13'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}, {'type': 'SECONDARY', 'title': 'Protein Delivery During the Intervention Period From Day 4 to Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Controle gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN gr', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '27', 'groupId': 'OG000'}, {'value': '100', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.', 'unitOfMeasure': 'percentage of protein target', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}, {'type': 'SECONDARY', 'title': 'Days in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.'}, {'id': 'OG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '39'}, {'value': '31', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'hospital length of stay', 'unitOfMeasure': 'days in hospital', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat analysis included all patients randomly assigned to the intervention SPN group (153) or control group EN (152). The per protocol analysis included only patients who fully completed the 5-day intervention in the ICU (SPN group(133); EN group (142).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.'}, {'id': 'FG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.'}, {'id': 'BG001', 'title': 'SPN Group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.\n\nSPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '16', 'groupId': 'BG000'}, {'value': '61', 'spread': '16', 'groupId': 'BG001'}, {'value': '60', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-18', 'studyFirstSubmitDate': '2008-12-03', 'resultsFirstSubmitDate': '2013-01-07', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-18', 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Documented Infection Rate', 'timeFrame': '20 days', 'description': 'Infection, defined according to CDC criteria during the ICU and hospital stay, occurrence between day 9 and day 28'}], 'secondaryOutcomes': [{'measure': 'Hours on Mechanical Ventilation in All Patients', 'timeFrame': '28 days', 'description': 'Mechanical ventilation hours during study duration (days 1-28)'}, {'measure': 'Antibiotic Free Days', 'timeFrame': '20 days', 'description': 'Number of days between day 9 to day 28 (follow-up period) free of antibiotics'}, {'measure': 'Total Energy Intake During the Intervention Period , Between Day 4 and Day 8.', 'timeFrame': '5 days', 'description': 'Percentage of energy target; in the SPN group the goal was to achieve 100% of the energy target during intervention (day 4 to day 8.The energy target was measured by indirect calorimetry in 198 patients of 305(65%),otherwise energy target was calculated by 25 kcal per kg of ideal body weight for women and 30 kcal per kg of ideal body weight for men and anamnestic body weight was used for patients with a body mass index of 20 kg/m2 or lower.'}, {'measure': 'General Mortality', 'timeFrame': '28 days'}, {'measure': 'Days in ICU', 'timeFrame': '28 days', 'description': 'Days in ICU'}, {'measure': 'ICU Mortality', 'timeFrame': '28 days'}, {'measure': 'Protein Delivery During the Intervention Period From Day 4 to Day 8', 'timeFrame': '5 days', 'description': 'Percentage of protein target between day 4 to 8. Protein target was set to 1.2 g per kg of ideal body weight a day.'}, {'measure': 'Days in Hospital', 'timeFrame': '28 days', 'description': 'hospital length of stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Critically ill', 'nutrition', 'randomised controlled clinical trial', 'human', 'adult', 'Supplemental parenteral nutrition'], 'conditions': ['Critically Ill']}, 'referencesModule': {'references': [{'pmid': '17468845', 'type': 'BACKGROUND', 'citation': 'Heidegger CP, Romand JA, Treggiari MM, Pichard C. Is it now time to promote mixed enteral and parenteral nutrition for the critically ill patient? Intensive Care Med. 2007 Jun;33(6):963-9. doi: 10.1007/s00134-007-0654-7. Epub 2007 Apr 28.'}, {'pmid': '23218813', 'type': 'DERIVED', 'citation': 'Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a standard of care. However, EN alone is often associated with insufficient energy intakes and increased complication rates. Recently the investigators proposed to decrease this deficit by combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (\\< 60% of their predicted energy needs) at day 3 after admission in the ICU.\n\nObjective: This study aims at: a/ investigating if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.\n\nStudy design: Prospective, controlled, randomized clinical study.\n\nStudy site: Service of Intensive Care, Geneva University Hospital.\n\nPatient population: 220 ICU patients to be included: expected length of stay \\> 5 days, expected survival \\> 7 days, no contraindication to EN, obtained informed consent from themselves or their next of keen.\n\nExclusion criteria: refusal of consent, age \\< 18 years, short bowel syndrome, significant persistent gastrointestinal dysfunction with ileus, high output proximal fistula (\\> 1,5 liter/d), patients receiving PN.\n\nNutrition: At day 3 after admission, if energy input is \\< 60%; patients are randomized into either the "Control group" (EN alone) or the "SPN group" (EN + PN) to reach 100% of their predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved according to our local practice by insulin administration.\n\nStudy endpoints:\n\n* Primary: nosocomial infections (CDC criteria)\n* Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic free days, ICU complications (extra-renal epuration, neurological, cardiac and respiratory complications), energy and protein balance, 28 days clinical outcome.', 'detailedDescription': "Introduction:\n\nNutritional support of the intensive care (ICU) patients is recommended as a standard of care. It is also strongly recommended to start enteral feeding as soon as possible whenever the gastrointestinal tract is functioning (1). However, studies have repeatedly shown that with enteral support alone, insufficient energy and protein intakes often occur (2). The resulting energy and protein deficit is associated with an increased complication rate in ICU patients (3-5). Recently we proposed to decrease this deficit by promoting a combined nutrition support by enteral nutrition (EN) and supplemental parenteral nutrition (SPN) whenever EN is insufficient (6).\n\nContrary to former beliefs, recent meta-analyses show that parenteral nutrition (PN) does not carry excess mortality (7, 8). These reports convey a concept that is a major break-through in current routine of nutritional support in ICU patients by promoting a much wider use of PN. SPN could be the optimal modality to provide the calculated energy targets if this cannot be reached by EN alone. To improve ICU patient's outcome and minimise complications, we propose to implement feeding protocols which combine both EN and PN, when EN is insufficient to cover more than 60% of caloric needs at day 4 to reach 100% of the energy targets by adding PN from day 4 (6).\n\nHypothesis:\n\nThe administration of SPN, in ICU patients receiving \\< 60% of targeted energy needs by EN alone, has a positive impact on their clinical outcome by optimising their nutritional support (reduced infectious complications rate, mechanical ventilation days, duration of ICU and hospital length of stay and rehabilitation).\n\nObjective:\n\nThe aim of the present study is to investigate if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients achieved with the combined administration of SPN and EN optimizes their clinical outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Expected ICU stay \\> 5 days\n* Expected survival \\> 7 days\n* No contraindication to EN\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Refusal of consent\n* Age \\< 18 years\n* Short bowel syndrome\n* Significant persistent gastrointestinal dysfunction with ileus\n* High output proximal fistula (\\> 1.5 liter/d)\n* Patients receiving PN'}, 'identificationModule': {'nctId': 'NCT00802503', 'briefTitle': 'Impact of SPN on Infection Rate, Duration of Mechanical Ventilation & Rehabilitation in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Impact of Supplemental Parenteral Nutrition (SPN) on Infection Rate, Duration of Mechanical Ventilation and Rehabilitation in Intensive Care Unit Patients: A Quality Control Program for the Implementing of New Nutrition Guidelines', 'orgStudyIdInfo': {'id': 'Protocole 07-098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPN group', 'description': 'experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.\n\nIn the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.', 'interventionNames': ['Dietary Supplement: SPN']}, {'type': 'NO_INTERVENTION', 'label': 'Control gr', 'description': 'EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.'}], 'interventions': [{'name': 'SPN', 'type': 'DIETARY_SUPPLEMENT', 'description': 'SPN : in the treated group, SPN is started if at day 4 energy input by EN is \\< 60% of energy target in order to reach 100% of energy target by peripheral or central line.', 'armGroupLabels': ['SPN group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Service of Intensive Care, Geneva University Hospital,', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Service de Médecine Intensive Adulte et Centre des Brûlés', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Claudia P HEIDEGGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Intensive Care, 1211 Geneva 14, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy head physician', 'investigatorFullName': 'HEIDEGGER CP', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}