Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-31 @ 12:47 AM
Study NCT ID:
NCT06453967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the effect of glucose variability during ICU admission on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure ▪', 'timeFrame': '1 year', 'description': 'Glycaemic variability can be measured by Standard deviation of glucose, Coefficient of variation of glucose, Mean amplitude of glucose excursion ,glycemic lability index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glucose variability'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '36572923', 'type': 'BACKGROUND', 'citation': "Zhou Y, Liu L, Huang H, Li N, He J, Yao H, Tang X, Chen X, Zhang S, Shi Q, Qu F, Wang S, Wang M, Shu C, Zeng Y, Tian H, Zhu Y, Su B, Li S; WECODe Study Group. 'Stress hyperglycemia ratio and in-hospital prognosis in non-surgical patients with heart failure and type 2 diabetes. Cardiovasc Diabetol. 2022 Dec 26;21(1):290. doi: 10.1186/s12933-022-01728-w."}, {'pmid': '36435766', 'type': 'BACKGROUND', 'citation': 'Djupsjo C, Kuhl J, Andersson T, Lundback M, Holzmann MJ, Nystrom T. Admission glucose as a prognostic marker for all-cause mortality and cardiovascular disease. Cardiovasc Diabetol. 2022 Nov 26;21(1):258. doi: 10.1186/s12933-022-01699-y.'}, {'pmid': '34560876', 'type': 'BACKGROUND', 'citation': 'Paolisso P, Foa A, Bergamaschi L, Angeli F, Fabrizio M, Donati F, Toniolo S, Chiti C, Rinaldi A, Stefanizzi A, Armillotta M, Sansonetti A, Magnani I, Iannopollo G, Rucci P, Casella G, Galie N, Pizzi C. Impact of admission hyperglycemia on short and long-term prognosis in acute myocardial infarction: MINOCA versus MIOCA. Cardiovasc Diabetol. 2021 Sep 24;20(1):192. doi: 10.1186/s12933-021-01384-6.'}, {'pmid': '36262366', 'type': 'BACKGROUND', 'citation': 'Lee HY, Oh BH. Paradigm Shifts of Heart Failure Therapy: Do We Need Another Paradigm? Int J Heart Fail. 2020 Apr 6;2(3):145-156. doi: 10.36628/ijhf.2020.0010. eCollection 2020 Jul.'}, {'pmid': '27554050', 'type': 'BACKGROUND', 'citation': 'Kattel S, Kasai T, Matsumoto H, Yatsu S, Murata A, Kato T, Suda S, Hiki M, Takagi A, Daida H. Association between elevated blood glucose level on admission and long-term mortality in patients with acute decompensated heart failure. J Cardiol. 2017 Apr;69(4):619-624. doi: 10.1016/j.jjcc.2016.05.013. Epub 2016 Aug 21.'}, {'pmid': '31935874', 'type': 'BACKGROUND', 'citation': 'Cho JY, Kim KH, Lee SE, Cho HJ, Lee HY, Choi JO, Jeon ES, Kim MS, Kim JJ, Hwang KK, Chae SC, Baek SH, Kang SM, Choi DJ, Yoo BS, Ahn Y, Park HY, Cho MC, Oh BH. Admission Hyperglycemia as a Predictor of Mortality in Acute Heart Failure: Comparison between the Diabetics and Non-Diabetics. J Clin Med. 2020 Jan 6;9(1):149. doi: 10.3390/jcm9010149.'}, {'pmid': '34740359', 'type': 'BACKGROUND', 'citation': 'Ceriello A, Catrinoiu D, Chandramouli C, Cosentino F, Dombrowsky AC, Itzhak B, Lalic NM, Prattichizzo F, Schnell O, Seferovic PM, Valensi P, Standl E; D&CVD EASD Study Group. Heart failure in type 2 diabetes: current perspectives on screening, diagnosis and management. Cardiovasc Diabetol. 2021 Nov 6;20(1):218. doi: 10.1186/s12933-021-01408-1.'}, {'pmid': '35796765', 'type': 'BACKGROUND', 'citation': 'Pop-Busui R, Januzzi JL, Bruemmer D, Butalia S, Green JB, Horton WB, Knight C, Levi M, Rasouli N, Richardson CR. Heart Failure: An Underappreciated Complication of Diabetes. A Consensus Report of the American Diabetes Association. Diabetes Care. 2022 Jul 7;45(7):1670-1690. doi: 10.2337/dci22-0014.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of blood glucose level at admission and glucose variability during ICU admission and their effect on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure', 'detailedDescription': 'Stress hyperglycemia is a physiological response of blood glucose levels to stressful events or severe diseases through enhanced inflammatory or neuro-hormonal activation , typically reflecting the severity of the corresponding disease.\n\nDiabetes mellitus may lead to hyperglycemia. However, it can happen as a result of stress hormones in crucial situations as well as in illness states, and is referred to as "Stress Hyperglycemia". Other names for this syndrome include "New onset Hyperglycemia", "In hospital Hyperglycemia", "Admission Hyperglycemia", "New Hyperglycemia", and "reactive Hyperglycemia". The prevalence of admission hyperglycaemia ranges from 25 to 50% depending on the hyperglycaemia definition cut-off adopted. The American Heart Association and the Endocrine Society Clinical Guidelines defined stress hyperglycaemia as a random plasma glucose level above 140 mg/dL at any given time for both diabetic and nondiabetic hospitalized patients.Studies have shown that an elevated admission blood glucose level, in correlation with a specific condition, such as: myocardial infarction, stroke, heart failure or pneumonia is associated with a higher in-hospital mortality, increased length of hospital stay, and a higher rate of in-hospital complications.\n\nHeart failure (HF) is a complex clinical syndrome that results from structural or functional impairment of ventricular filling or ejection. Also, HF is a progressive condition with intermittent acute decompensation leading to poor prognosis despite established guideline-directed therapy.Acute decompensated heart failure is a common reason for frequent hospital admission and has been associated with increased short-term mortality and poor long-term prognosis. Admission hyperglycaemia can be useful in identifying high-risk group of acute heart failure or in the risk stratification of acute heart failure In addition to age, obesity and diabetes have been identified as important risk factors for heart failure, Heart failure often manifests as the first cardiovascular event in people with type 2 diabetes.Several potential mechanisms contributing to the development of heart failure in diabetes include renin-angiotensin-aldosterone system (RAAS) activation, mitochondrial dysfunction, oxidative stress, inflammation, changes in intracellular calcium homeostasis, increased formation of advanced glycation end products, and myocardial energy substrate alterations including increased free fatty acid utilization, decreased glucose utilization, and increased oxygen consumption, resulting in decreased cardiac efficiency .\n\nDysregulation of hyperglycemia and glycemic variability are associated with an increased risk of mortality in critically ill patients .\n\nIt is also to be noted that individuals with HF and pre-diabetes have a higher risk of all-cause mortality and cardiac outcomes compared to those with normoglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients diagnosed as acute decompensated heart failure and admitted to critical care unit will be recurited in this study either diabetic or not', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted with acute decompensated heart failure will be recruited in the study.\n\nExclusion Criteria:\n\n* Patients on chronic steroid therapy Patients diagnosed with right sided heart failure due to chest disease Patients with malignancy'}, 'identificationModule': {'nctId': 'NCT06453967', 'briefTitle': 'Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': '2024-04-22-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood glucose levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of blood glucose level at admission ,during ICU admission and at discharge for patients with acute decompensated heart failure'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'salma Hamdy, master degree', 'role': 'CONTACT', 'email': 'salmahamdy003@gmail.com', 'phone': '01012681274'}, {'name': 'mohamed hassan, MD', 'role': 'CONTACT', 'email': 'mhmdifferent@aun.edu.eg', 'phone': '01115353591'}], 'overallOfficials': [{'name': 'Ahmed Obeid Allah, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'salma hamdy mahmoud haridi', 'investigatorAffiliation': 'Assiut University'}}}}