Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-27 @ 10:54 AM
Study NCT ID:
NCT01581957
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2012-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2012-04-18', 'studyFirstSubmitQcDate': '2012-04-18', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diarrhea-free days during Enteral Nutrition (EN) administration to the patients in the Intensive Care Unit (ICU)', 'timeFrame': 'from EN start until end of treatment or ICU discharge (whatever comes first)', 'description': 'Patients will receive treatment for 10 days maximum'}, {'measure': 'Number of diarrhea events per day during EN administration to the patients in the Intensive Care Unit (ICU)', 'timeFrame': 'from EN start until end of treatment or ICU discharge (whatever comes firts)', 'description': 'Patients will receive treatment for 10 days maximum'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of diarrhea', 'timeFrame': 'up to 10 days', 'description': '* Number of patients that experienced diarrhea during ICU stay\n* Interruption of EN due to diarrhea\n* Presence/absence of electrolyte and acid-base disturbances secondary to diarrhea'}, {'measure': 'Presence/absence of other abdominal symptoms', 'timeFrame': 'up to 10 days', 'description': 'If present: description of abdominal distension, pain, absence of bowel sounds'}, {'measure': 'Changes in intra-abdominal pressure', 'timeFrame': 'up to 10 days'}, {'measure': 'Incidence of nausea, vomiting and regurgitation', 'timeFrame': 'up to 10 days'}, {'measure': 'Gastric residual volumes (>500 ml)', 'timeFrame': 'up to 10 days'}, {'measure': 'Need to use any drug interfering with the passage of nutrition', 'timeFrame': 'up to 10 days'}, {'measure': 'Visual analogue scale for abdominal discomfort', 'timeFrame': 'up to 10 days', 'description': 'Assessed in non-comatose patients'}, {'measure': 'Health Economic burden of Diarrhea during EN administration at ICU', 'timeFrame': 'up to 10 days', 'description': '* Nurse workload for the management of patients with diarrhea during the EN feeding period in ICU\n* Total cost of diarrhea evaluated for each patient who experienced diarrhea (medications, cleaning material, blankets, etc.)'}, {'measure': 'For blood glucose control', 'timeFrame': 'up to 10 days', 'description': '* Number of events outside the 4.5 to 10 mmol/l glycaemic range\n* Need for insulin unit administration during exclusive enteral nutrition\n* Need for glucose administration during exclusive enteral nutrition'}, {'measure': 'Time to reach the full caloric goal', 'timeFrame': 'up to 10 days', 'description': '25 Kcal/kg/day or as determined for each patient with indirect calorimetry'}, {'measure': 'Accumulated daily caloric deficit during 72 hs after start of the study', 'timeFrame': 'up to 10 days', 'description': 'Percentage of cumulative calories delivered vs. prescribed during hospitalization in ICU and accumulated deficit during ICU stay/day (it should be the same)'}, {'measure': 'Need for parenteral nutrition supplementation during ICU stay', 'timeFrame': 'up to 10 days', 'description': 'yes/no, economic impact'}, {'measure': 'Nutritional assessment', 'timeFrame': 'up to 10 days', 'description': 'serum albumin at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first)'}, {'measure': 'Incidence of secondary infections', 'timeFrame': 'up to 10 days'}, {'measure': 'ICU Length of Stay, days on mechanical ventilation during ICU stay (mech. ventilation-free days), hospital LOS (length of stay)', 'timeFrame': 'up to 28 days'}, {'measure': 'Microbiota profiling', 'timeFrame': 'up to 10 days', 'description': 'Comprehensive intestinal microbiota profiling by sequencing-based approaches in stool samples collected right before initiation of EN, 3 days after EN start, at treatment end or at ICU discharge (whatever comes first), and at diarrhea episodes'}, {'measure': 'Determination of diarrhea pathogenicity', 'timeFrame': 'up to 10 days', 'description': 'Infections, fecal cultures for pathogens assessed at diarrhea episodes'}, {'measure': 'Safety evaluation (blood sampling)', 'timeFrame': 'up to 10 days', 'description': 'End-point of safety evaluation at baseline, 3 days after EN start and at treatment end or at ICU discharge (whatever comes first), will include: blood cell analysis, hemoglobin, hepatic enzymes and creatinine'}, {'measure': 'AEs (adverse events) / SAEs (serious adverse events)', 'timeFrame': 'up to 28 days', 'description': 'AE and SAE reporting from study start until 28 days after randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Enteral nutrition, critically ill patients'], 'conditions': ['Critically Ill']}, 'referencesModule': {'references': [{'pmid': '28599662', 'type': 'DERIVED', 'citation': 'Jakob SM, Butikofer L, Berger D, Coslovsky M, Takala J. A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient-the SPIRIT trial. Crit Care. 2017 Jun 10;21(1):140. doi: 10.1186/s13054-017-1730-1.'}]}, 'descriptionModule': {'briefSummary': 'Specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient.\n\nThis pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female older than 18 years of age\n* All ICU patients\n* Expected ICU stay superior or equal to 5 days\n* Anticipated to receive tube feeding for at least 3 days\n* Informed consent obtained from patient or close relative\n\nExclusion Criteria:\n\n* Contraindication to enteral nutrition or to the placement of an enteral feeding tube\n* On enteral nutrition with superior or equal to 75% of caloric goal administered\n* Restriction in full intestinal support including protein administration\n* Parenteral nutrition of any kind unless due to enteral nutrition intolerance\n* History of allergy or intolerance to the study product components (test or control product)\n* Currently under therapeutic limitations. Non functional GI tract\n* Unwilling or unable to comply with study treatments\n* Currently participating or having participated in another clinical, interventional trial during the last month'}, 'identificationModule': {'nctId': 'NCT01581957', 'acronym': 'SPIRIT', 'briefTitle': 'Pilot Study on Gastro-intestinal (GI) Enteral Nutrition (EN) Tolerance in Intensive Care Unit Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'A Pilot Study to Evaluate the Effect of a Specific Enteral Formulation Designed to Improve Gastrointestinal Tolerance in the Critically Ill Patient', 'orgStudyIdInfo': {'id': '10.10.CLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Specific Enteral formulation', 'interventionNames': ['Other: Specific Enteral Nutrition']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard enteral formulation', 'interventionNames': ['Other: Standard Enteral Nutrition']}], 'interventions': [{'name': 'Specific Enteral Nutrition', 'type': 'OTHER', 'description': 'Patients will receive a Specific EN. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).', 'armGroupLabels': ['Specific Enteral formulation']}, {'name': 'Standard Enteral Nutrition', 'type': 'OTHER', 'description': 'Patients will receive an equivalent volume and caloric intake of standard formulation. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).', 'armGroupLabels': ['Standard enteral formulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bern', 'state': 'Canton of Bern', 'country': 'Switzerland', 'facility': 'Department of Intensive Care Medicine. Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Stephan Jakob, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}