Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-10 @ 3:31 PM
Study NCT ID:
NCT00993057
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2009-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D002532', 'term': 'Intracranial Aneurysm'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D061386', 'term': 'Insulin, Regular, Human'}], '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2009-10-08', 'studyFirstSubmitQcDate': '2009-10-08', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'performance of each of glucose sampling and insulin protocols for achieving euglycemia', 'timeFrame': 'duration of operation', 'description': 'performance of each of glucose sampling and insulin protocols for achieving euglycemia during the operation'}], 'secondaryOutcomes': [{'measure': 'hypoglycemia', 'timeFrame': 'duration of operation', 'description': 'Hypoglycemia occurring the operation'}, {'measure': 'time required to reach euglycemia', 'timeFrame': 'durarion of operation', 'description': 'Elapsed time required to reach euglycemia during the operation'}, {'measure': 'relationship of BMI and performance of protocols', 'timeFrame': 'duration of operation', 'description': 'Evaluating the relationship of BMI (Body Mass Index) and the performance of protocols during the operation'}, {'measure': 'relationship of serum biomarkers of insulin resistance and performance of protocols', 'timeFrame': 'duration of operation', 'description': 'Evaluating the relationship of serum biomarkers of insulin resistance and performance of protocols during the operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Euglycemia', 'craniotomy', 'neurosurgery', 'hypoglycemia', 'insulin'], 'conditions': ['Brain Neoplasms', 'Intracranial Aneurysm']}, 'referencesModule': {'references': [{'pmid': '17573393', 'type': 'BACKGROUND', 'citation': 'Fukuda S, Warner DS. Cerebral protection. Br J Anaesth. 2007 Jul;99(1):10-7. doi: 10.1093/bja/aem140.'}, {'pmid': '15781533', 'type': 'BACKGROUND', 'citation': 'Lukins MB, Manninen PH. Hyperglycemia in patients administered dexamethasone for craniotomy. Anesth Analg. 2005 Apr;100(4):1129-1133. doi: 10.1213/01.ANE.0000146943.45445.55.'}, {'pmid': '14757880', 'type': 'BACKGROUND', 'citation': 'Lindsberg PJ, Roine RO. Hyperglycemia in acute stroke. Stroke. 2004 Feb;35(2):363-4. doi: 10.1161/01.STR.0000115297.92132.84. No abstract available.'}, {'pmid': '18380986', 'type': 'BACKGROUND', 'citation': 'Pasternak JJ, McGregor DG, Schroeder DR, Lanier WL, Shi Q, Hindman BJ, Clarke WR, Torner JC, Weeks JB, Todd MM; IHAST Investigators. Hyperglycemia in patients undergoing cerebral aneurysm surgery: its association with long-term gross neurologic and neuropsychological function. Mayo Clin Proc. 2008 Apr;83(4):406-17. doi: 10.4065/83.4.406.'}, {'pmid': '15271698', 'type': 'BACKGROUND', 'citation': 'Carvalho G, Moore A, Qizilbash B, Lachapelle K, Schricker T. Maintenance of normoglycemia during cardiac surgery. Anesth Analg. 2004 Aug;99(2):319-24, table of contents. doi: 10.1213/01.ANE.0000121769.62638.EB.'}, {'pmid': '16842191', 'type': 'BACKGROUND', 'citation': 'Geroldi D, Falcone C, Emanuele E. Soluble receptor for advanced glycation end products: from disease marker to potential therapeutic target. Curr Med Chem. 2006;13(17):1971-8. doi: 10.2174/092986706777585013.'}, {'pmid': '17951292', 'type': 'BACKGROUND', 'citation': 'Meng YX, Ford ES, Li C, Quarshie A, Al-Mahmoud AM, Giles W, Gibbons GH, Strayhorn G. Association of C-reactive protein with surrogate measures of insulin resistance among nondiabetic US from National Health and Nutrition Examination Survey 1999-2002. Clin Chem. 2007 Dec;53(12):2152-9. doi: 10.1373/clinchem.2007.088930. Epub 2007 Oct 19.'}, {'pmid': '18505888', 'type': 'BACKGROUND', 'citation': 'Olufadi R, Byrne CD. Clinical and laboratory diagnosis of the metabolic syndrome. J Clin Pathol. 2008 Jun;61(6):697-706. doi: 10.1136/jcp.2007.048363.'}, {'pmid': '11479627', 'type': 'BACKGROUND', 'citation': 'Yamauchi T, Kamon J, Waki H, Terauchi Y, Kubota N, Hara K, Mori Y, Ide T, Murakami K, Tsuboyama-Kasaoka N, Ezaki O, Akanuma Y, Gavrilova O, Vinson C, Reitman ML, Kagechika H, Shudo K, Yoda M, Nakano Y, Tobe K, Nagai R, Kimura S, Tomita M, Froguel P, Kadowaki T. The fat-derived hormone adiponectin reverses insulin resistance associated with both lipoatrophy and obesity. Nat Med. 2001 Aug;7(8):941-6. doi: 10.1038/90984.'}, {'pmid': '10195925', 'type': 'BACKGROUND', 'citation': 'Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.'}, {'pmid': '1588504', 'type': 'BACKGROUND', 'citation': 'Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992 Feb;20(1):63-94. doi: 10.1007/BF01143186.'}]}, 'descriptionModule': {'briefSummary': 'What is the efficacy and safety of q 30 minutes vs. q 1hour glucose sampling and intervention for an intensive insulin protocol to achieve and maintain euglycemia in non-diabetic patients undergoing craniotomy? The investigators hypothesize that in non-diabetic patients undergoing craniotomy, monitoring glucose and modifying insulin infusions every 30 minutes compared to every hour will help them reach target glucose levels faster and maintain them more efficiently with the same insulin protocol.', 'detailedDescription': 'Intraoperative blood glucose levels will be maintained in the target range of 90-110 mg/dL (euglycemia) using the protocol. The target serum glucose ranges chosen (90-110 mg/dL) was chosen to specifically target those levels associated with the best outcome in cerebral aneurysm surgery (serum glucose \\< 108 mg/dL) and aggressively avoid those levels associated with cognitive dysfunction (serum glucose \\< 128 mg/dL) and gross neurologic deficits (serum glucose \\< 152 mg/dL). Because the strength of these data, the investigators utilize an aggressive insulin protocol in their routine clinical care of patients undergoing craniotomies.\n\nEach patient will be randomly assigned to one of two frequency of intervention groups-Group 30 will have the insulin dose adjusted every 30 minutes and Group 60 will have the insulin dose adjusted every 60 minutes. Blood glucose levels, insulin boluses and infusion rates, and dextrose boluses will be recorded on the respective Intraoperative Insulin \\& Glucose data sheet (Appendix 2 and 3 for Group 30 and Group 60, respectively).\n\nRegardless of the protocol, glucose measurements will be conducted every 15 minutes but insulin intervention will be done at 30 minutes or one hour (per assigned treatment group). The interval data (15 minutes for the 30 min group and 15, 30, and 45 minutes for the 1 hour group) will be utilized to determine the pharmacodynamic effects of insulin (dose-response relationship). Interventions will only be performed at the assigned interval (30 vs 60 min) unless the glucose level is \\< 70 mg/dL, at which time the patient will receive 25 mL of 50% Dextrose solution. For these rescued patients, the protocol will be continued as scheduled.\n\nOn the day of surgery, after confirming entry into the study (i.e., confirmation of research consent), each patient will be randomly assigned to a specific protocol-q 30 minutes glucose measurements and intervention vs. q 60 minutes glucose measurements and intervention.Randomization will be performed in blocks of 10 using a computer generated random number assignment (odd numbers = q 30 minutes and even numbers = q 60 minutes)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All English speaking, non-diabetic, non-pregnant patients over the age of 18 undergoing open craniotomy for the surgical treatment of tumors or intracranial aneurysms.\n\nExclusion Criteria:\n\n* Patients under 18 years of age, patients who are pregnant, patients with diabetes, BMI \\> 33 kg/m2.'}, 'identificationModule': {'nctId': 'NCT00993057', 'briefTitle': 'Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Comparing Two Glucose Sampling Frequencies for an Intensive Insulin Protocol During Craniotomy in Non-Diabetic Patients-How Efficiently and Safely Can We Maintain Target Glucose Levels', 'orgStudyIdInfo': {'id': 'STU00009023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Q1 hour protocol', 'description': 'change of insulin infusion every hour', 'interventionNames': ['Drug: Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Q30min protocol', 'description': 'change of insulin infusion every 30 minutes', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['Humulin'], 'description': 'Adjustable insulin infusion scale with loading doses', 'armGroupLabels': ['Q1 hour protocol', 'Q30min protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Dhanesh Gupta', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Dhanesh Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in Anesthesiology and Neurological Surgery', 'investigatorFullName': 'John Bebawy', 'investigatorAffiliation': 'Northwestern University'}}}}