Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT01775020
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2013-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose-response Study of Arginine Supplementation in Severe Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2013-01-21', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nitric oxide synthesis', 'timeFrame': '8 hours', 'description': 'Nitric oxide synthesis at step-wise increasing doses of L-arginine infusion. Following a 2h baseline measurements, 3 stepwise increasing arginine doses each provided for 2h will be tested for the effect on NO synthesis.'}], 'secondaryOutcomes': [{'measure': 'hemodynamics', 'timeFrame': '8 hours', 'description': 'Mean arterial pressure (MAP), pulmonary arterial pressure (PAP), cardiac output (CO), cardiac index (CI), heart rate (HR)'}, {'measure': 'blood parameters', 'timeFrame': '8 hours', 'description': 'Blood gasses, electrolytes, glucose, insulin, amino acids, whole body protein and arginine metabolism'}, {'measure': 'gastric perfusion', 'timeFrame': '8 hours', 'description': 'Regional (gastric) CO2 production measured with tonometry (PrCO2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '19056593', 'type': 'BACKGROUND', 'citation': 'Luiking YC, Poeze M, Ramsay G, Deutz NE. Reduced citrulline production in sepsis is related to diminished de novo arginine and nitric oxide production. Am J Clin Nutr. 2009 Jan;89(1):142-52. doi: 10.3945/ajcn.2007.25765. Epub 2008 Dec 3.'}, {'pmid': '21508091', 'type': 'BACKGROUND', 'citation': 'Poeze M, Bruins MJ, Kessels F, Luiking YC, Lamers WH, Deutz NE. Effects of L-arginine pretreatment on nitric oxide metabolism and hepatosplanchnic perfusion during porcine endotoxemia. Am J Clin Nutr. 2011 Jun;93(6):1237-47. doi: 10.3945/ajcn.110.007237. Epub 2011 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'Pilot data in patients and data from pig studies indicate that arginine-NO metabolism is impaired in sepsis with changes in splanchnic metabolism and function, and reduced survival at low nitrate levels. Prolonged intravenous supplementation of L-arginine proved effective in pigs for increasing NO production, restoring gut function, and inhibiting an increase in pulmonary arterial pressure, without any deleterious systemic side effects. Prolonged intravenous L-arginine supplementation could therefore be useful in septic ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent from close relative\n* Age \\> 18 years\n* Patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion (see appendix A; in Dutch).\n* Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure \\<15 mm Hg) during 2 h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration.\n* Systemic and pulmonary arterial catheters in place with continuous pressure monitoring.\n* Patients in whom the clinician is prepared to provide full life support during the duration of the study, including a life expectance of \\> 24 h.\n\nExclusion Criteria:\n\n* Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.)\n* Corticosteroid use (prolonged intake of \\> 1mg/kg daily or intake of \\> 70 mg/day for 7 consecutive days within 1 month preceding the study)\n* Liver cirrhosis\n* Chronic pancreatitis\n* Diabetes mellitus type I\n* Metastases, haematological malignancies or chemotherapy\n* Patients on dialysis (CVVH or other)'}, 'identificationModule': {'nctId': 'NCT01775020', 'briefTitle': 'Dose-response Study of Arginine Supplementation in Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Arginine and Nitric Oxide (NO) Metabolism in Sepsis; Dose-response Study on the Effect of L-arginine Supplementation on NO Metabolism and Gastric Perfusion in Severe Septic Patients.', 'orgStudyIdInfo': {'id': 'MEC03-139.5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-arginine', 'description': 'L-arginine', 'interventionNames': ['Dietary Supplement: L-arginine']}], 'interventions': [{'name': 'L-arginine', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['L-arginine-HCl'], 'armGroupLabels': ['L-arginine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nicolaas E Deutz, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Medical Nutrition', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}