Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-04-14 @ 8:44 PM
Study NCT ID:
NCT02516358
Status:
UNKNOWN
Last Update Posted:
2015-09-01
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycaemic Alterations in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-31', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-08-03', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glycaemic blood levels during ICU stay', 'timeFrame': 'Glycaemic values expressed as mean glycaemia will be collected at the baseline and every 8 hours for the duration of ICU stay, expected average of 10 days per patient.'}], 'secondaryOutcomes': [{'measure': 'Episodes of hypoglicaemia (number)', 'timeFrame': 'For the duration of ICU stay, expected average of 10 days per patient.'}, {'measure': 'Episodes of hyperglycaemia (number)', 'timeFrame': 'For the duration of ICU stay, expected average of 10 days per patient.'}, {'measure': 'Coefficient of variation of blood glucose levels', 'timeFrame': 'Time point A:24 hours. Time point B: 48 hours after ICU admission. Time point C: for the duration of ICU stay, an expected average of 10 days per patient.', 'description': 'Coefficient of Variation, calculated as a percentage'}, {'measure': 'Time in glycaemic Range (TIR)', 'timeFrame': 'Time point A:24 hours. Time point B: 48 hours after ICU admission. Time point C: for the duration of ICU stay, an expected average of 10 days per patient.', 'description': 'Evaluated in hours TIR/ total hours in ICU; calculated as a percentage'}, {'measure': 'Days of mechanical ventilation', 'timeFrame': 'Participants will be followed for the duration of ICU stay, expected average per patient: 10 days'}, {'measure': 'Days of continuous renal replacement therapy', 'timeFrame': 'Participants will be followed for the duration of ICU stay, expected average per patient: 10 days'}, {'measure': 'Neuron Specific Enolase (NSE) blood levels and glycaemic disorders', 'timeFrame': 'NSE collection: Time point A: ICU admission. Time point NSE: 48-72 hours after ICU admission', 'description': 'To detect a correlation between NSE levels and glycaemic alterations in both diabetic and non diabetic patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '15364770', 'type': 'BACKGROUND', 'citation': 'Cely CM, Arora P, Quartin AA, Kett DH, Schein RM. Relationship of baseline glucose homeostasis to hyperglycemia during medical critical illness. Chest. 2004 Sep;126(3):879-87. doi: 10.1378/chest.126.3.879.'}, {'pmid': '25888011', 'type': 'BACKGROUND', 'citation': 'Kalfon P, Le Manach Y, Ichai C, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Severe and multiple hypoglycemic episodes are associated with increased risk of death in ICU patients. Crit Care. 2015 Apr 8;19(1):153. doi: 10.1186/s13054-015-0851-7.'}, {'pmid': '18664780', 'type': 'BACKGROUND', 'citation': 'Egi M, Bellomo R, Stachowski E, French CJ, Hart GK, Hegarty C, Bailey M. Blood glucose concentration and outcome of critical illness: the impact of diabetes. Crit Care Med. 2008 Aug;36(8):2249-55. doi: 10.1097/CCM.0b013e318181039a.'}, {'pmid': '23452622', 'type': 'BACKGROUND', 'citation': 'Krinsley JS, Egi M, Kiss A, Devendra AN, Schuetz P, Maurer PM, Schultz MJ, van Hooijdonk RT, Kiyoshi M, Mackenzie IM, Annane D, Stow P, Nasraway SA, Holewinski S, Holzinger U, Preiser JC, Vincent JL, Bellomo R. Diabetic status and the relation of the three domains of glycemic control to mortality in critically ill patients: an international multicenter cohort study. Crit Care. 2013 Mar 1;17(2):R37. doi: 10.1186/cc12547.'}, {'pmid': '24760120', 'type': 'BACKGROUND', 'citation': 'Plummer MP, Bellomo R, Cousins CE, Annink CE, Sundararajan K, Reddi BA, Raj JP, Chapman MJ, Horowitz M, Deane AM. Dysglycaemia in the critically ill and the interaction of chronic and acute glycaemia with mortality. Intensive Care Med. 2014 Jul;40(7):973-80. doi: 10.1007/s00134-014-3287-7. Epub 2014 Apr 24.'}, {'pmid': '9754808', 'type': 'BACKGROUND', 'citation': 'Sulter G, Elting JW, De Keyser J. Increased serum neuron specific enolase concentrations in patients with hyperglycemic cortical ischemic stroke. Neurosci Lett. 1998 Aug 28;253(1):71-3. doi: 10.1016/s0304-3940(98)00595-3.'}, {'pmid': '22234163', 'type': 'BACKGROUND', 'citation': 'Krinsley JS, Meyfroidt G, van den Berghe G, Egi M, Bellomo R. The impact of premorbid diabetic status on the relationship between the three domains of glycemic control and mortality in critically ill patients. Curr Opin Clin Nutr Metab Care. 2012 Mar;15(2):151-60. doi: 10.1097/MCO.0b013e32834f0009.'}, {'pmid': '25927986', 'type': 'BACKGROUND', 'citation': 'Krinsley JS, Preiser JC. Time in blood glucose range 70 to 140 mg/dl >80% is strongly associated with increased survival in non-diabetic critically ill adults. Crit Care. 2015 Apr 20;19(1):179. doi: 10.1186/s13054-015-0908-7.'}, {'pmid': '18388674', 'type': 'BACKGROUND', 'citation': 'Kochanek PM, Berger RP, Bayir H, Wagner AK, Jenkins LW, Clark RS. Biomarkers of primary and evolving damage in traumatic and ischemic brain injury: diagnosis, prognosis, probing mechanisms, and therapeutic decision making. Curr Opin Crit Care. 2008 Apr;14(2):135-41. doi: 10.1097/MCC.0b013e3282f57564.'}, {'pmid': '19318384', 'type': 'BACKGROUND', 'citation': 'NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.'}, {'pmid': '19465235', 'type': 'BACKGROUND', 'citation': 'Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.'}]}, 'descriptionModule': {'briefSummary': 'To quantify the local prevalence of diabetes mellitus in critically ill patients. To understand whether a correlation does exist between premorbid glycaemic control and glycaemic status in ICU. A subgroup analysis will be conducted to investigate whether a relationship does exist between Neuron Specific Enolase levels and glycaemic disorders.', 'detailedDescription': 'The aim of this study is to determine the local prevalence of critical illness-associated hyperglycaemia (CIAH) and recognised and unrecognised diabetes, as well as to evaluate how premorbid glycaemia impacts the relationship between three glycaemic domains and mortality.\n\nThe investigators will calculate the Time In Range (TIR, 70-180 mg/dl) and evaluate distribution of percentage time in range for non-diabetics and diabetics patients, in order to understand the association between TIR and survival in both groups of patients (patients with diabetes and patients without diabetes).\n\nIn view of the potential adverse effects of hyperglycaemia, hypoglycaemia and glycaemic variability on the brain, the investigators will dose Neuron Specific Enolase in critically ill patients.\n\nThe aim is to define if a biochemical correlation does exist between critically ill dysglycaemia and NSE plasma concentration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients\n* expected ICU length of stay \\> 48 hours\n\nExclusion Criteria:\n\n* age \\<18 years\n* ICU length of stay \\<48 hours\n* diabetic ketoacidosis\n* hyperosmolar nonketonic hyperglycaemia syndrome\n* pregnancy\n* hypoglycaemic coma\n* acute or acute on chronic liver failure, liver transplantation or end-stage liver disease.'}, 'identificationModule': {'nctId': 'NCT02516358', 'briefTitle': 'Glycaemic Alterations in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Glycaemic Alterations in ICU: an Observational, Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Gly 1'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Francesca Di Muzio', 'role': 'CONTACT', 'email': 'francescadimuzio@gmail.com', 'phone': '0467556315; 00393470333656'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Francesca Di Muzio', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}