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

June 10, 2024 updated by: salma hamdy mahmoud haridi, Assiut University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed as acute decompensated heart failure and admitted to critical care unit will be recurited in this study either diabetic or not

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the effect of glucose variability during ICU admission on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure ▪
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ahmed Obeid Allah, Phd, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-04-22-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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