Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT00282594
Status:
COMPLETED
Last Update Posted:
2006-01-27
First Post:
2006-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], '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': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2005-10'}, 'lastUpdateSubmitDate': '2006-01-26', 'studyFirstSubmitDate': '2006-01-26', 'studyFirstSubmitQcDate': '2006-01-26', 'lastUpdatePostDateStruct': {'date': '2006-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality'}], 'secondaryOutcomes': [{'measure': 'Length of ICU Stay'}, {'measure': 'Ventilatory Requirement'}, {'measure': 'Vasopressor Support'}, {'measure': 'Incidence of Renal Failure'}, {'measure': 'Incidence of Wound Infection'}]}, 'conditionsModule': {'keywords': ['Intensive Insulin Therapy', 'General Surgical', 'Vascular Surgical', 'Tight Glycemic Control'], 'conditions': ['Sepsis', 'Respiratory Failure', 'Renal Failure', 'Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '11794168', 'type': 'BACKGROUND', 'citation': 'van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.'}]}, 'descriptionModule': {'briefSummary': 'We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.', 'detailedDescription': 'While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability\n\n\\-\n\nExclusion Criteria:\n\n* Under age 18'}, 'identificationModule': {'nctId': 'NCT00282594', 'briefTitle': 'The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Genesys'}, 'officialTitle': 'No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.', 'orgStudyIdInfo': {'id': 'GRMC 050023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Novolin R (human recombinant Insulin)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Regional Medical Center', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}], 'overallOfficials': [{'name': 'Michael Kia, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ascension Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genesys', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}]}}}