Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

Heart Failure Clinical Trial

Official title:

Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453967
• Other study ID #: 2024-04-22-001
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: salma Hamdy, master degree
• Phone: 01012681274
• Email: salmahamdy003[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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. Diabetes 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. Heart 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 . Dysregulation of hyperglycemia and glycemic variability are associated with an increased risk of mortality in critically ill patients . It 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: September 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients admitted with acute decompensated heart failure will be recruited in the study.

Exclusion Criteria:

• Patients on chronic steroid therapy Patients diagnosed with right sided heart failure due to chest disease Patients with malignancy

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• blood glucose levels
measurement of blood glucose level at admission ,during ICU admission and at discharge for patients with acute decompensated heart failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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. — View 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. — View 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. Erratum In: Cardiovasc Diabetol. 2022 Dec 29;21(1):292. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of glucose variability during ICU admission on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure ?	Glycaemic variability can be measured by Standard deviation of glucose, Coefficient of variation of glucose, Mean amplitude of glucose excursion ,glycemic lability index	1 year