Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05238051
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2022-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastric Residual Volume Measurement in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Gastric residual volume (GRV) was measured in one group and not in the other. Nutrition was started at an infusion rate of 20 ml/hour in the GRV group. The GRV was measured every four hours. When it was less than 200 ml, the infusion rate was increased by 20 ml/hour. The infusion rate, which was increased every four hours according to the GRV, was continued constantly when the target calorie was reached. It was kept constant when the GRV was above 200 ml, and then the feeding rate was reduced to half when the GRV volume was above 400 ml. In four patients, enteral nutrition was discontinued due to melena and excluded from the study. In six patients with persistently high GRV values, enteral nutrition was discontinued and parenteral nutrition initiated. The study was completed with 62 patients. GRV (n=31) and Non-GRV (n=31).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in the time to reach target calories in patients with gastric residual volume measurement compared to those without gastric residual volume measurement.', 'timeFrame': '10 days', 'description': 'The difference in the time to reach target calories in patients with gastric residual volume measurement compared to those without gastric residual volume measurement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric residual volume', 'malnutrition', 'target calorie', 'intensive care unit', 'enteral nutrition'], 'conditions': ['Preventing Malnutrition']}, 'referencesModule': {'references': [{'pmid': '24296860', 'type': 'BACKGROUND', 'citation': 'Marik PE. Enteral nutrition in the critically ill: myths and misconceptions. Crit Care Med. 2014 Apr;42(4):962-9. doi: 10.1097/CCM.0000000000000051.'}, {'pmid': '25524884', 'type': 'BACKGROUND', 'citation': 'Elke G, Felbinger TW, Heyland DK. Gastric residual volume in critically ill patients: a dead marker or still alive? Nutr Clin Pract. 2015 Feb;30(1):59-71. doi: 10.1177/0884533614562841. Epub 2014 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'Nutritional support is considered a key component of the treatment strategy for intensive care patients. Malnutrition, energy protein, and inadequate or excessive intake of other nutrients have measurable effects on tissues, body structure, body function, and clinical outcomes of patients receiving treatment. It increases hospital-acquired infections, hospitalizations, and intensive care prolongs and leads to complications. This study aimed to observe the time to reach target calories, nutritional failures, and complications during feeding in measured and unmeasured gastric residual volume patients receiving enteral nutrition under ventilation in the intensive care unite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical ventilatory support\n* open enteral route (nasogastric/PEG)\n\nExclusion Criteria:\n\n* History of gastrointestinal bleeding,\n* parenteral nutrition support,\n* hospital stay of fewer than two days,\n* under 18 years of age'}, 'identificationModule': {'nctId': 'NCT05238051', 'briefTitle': 'Gastric Residual Volume Measurement in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan Binali Yildirim Universitesi'}, 'officialTitle': 'The Role of Gastric Residual Volume Measurement in Achieving Target Calories in the Intensive Care Unit: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'GRVROLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Gastric residual volume group', 'description': 'Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement in the intensive care unit'}, {'type': 'EXPERIMENTAL', 'label': 'Non- Gastric residual volume group', 'description': 'Patients undergoing enteral nutrition with continuous infusion and intermittent gastric residual volume measurement was not measured in the intensive care unit', 'interventionNames': ['Other: Gastric residual volume measurement stopped.']}], 'interventions': [{'name': 'Gastric residual volume measurement stopped.', 'type': 'OTHER', 'description': 'GRV is checked during routine enteral nutrition, but we think that GRV prolongs the time to reach target calories and does not reduce complications.', 'armGroupLabels': ['Non- Gastric residual volume group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24100', 'city': 'Erzincan', 'country': 'Turkey (Türkiye)', 'facility': 'Erzincan Binali Yildirim university', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan Binali Yildirim Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alparslan Koc', 'investigatorAffiliation': 'Erzincan University'}}}}