Prognostic Impact of Admission Glucose Level in Septic Patients Admitted to the Intensive Care Unit

NCT04740333 | Completed

• 1 other identifier: 0384-20-MMC
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sepsis is one of the most common reasons for admission to intensive care units (ICU) worldwide. About 30% of all patients admitted to intensive care suffer from sepsis (1). Sepsis causes an extreme physiological stress response, with significant changes in metabolism and disruption in glucose regulation. Disorder of glucose regulation can lead to hyperglycemia, hypoglycemia and glucose variability (2). All of these conditions are associated with increased mortality (3). In critically-ill patients, the glucose threshold from which damage may be caused remains controversial. Hyperglycemia often occurs in critically-ill patients suffering from sepsis, even in those who were not diabetic before, for several reasons. Sepsis causes massive activation of anti-inflammatory mediators which enhances the activity of counter-regulatory hormones, including cortisol, glucagon and catecholamines. Those hormones increase both hepatic gluconeogenesis and peripheral resistance to insulin (4). Some of the detrimental effects of hyperglycemia in septic patients are mediated via hyperglycemia-induced blood hypercoagulable state, decrease of vascular endothelial responsiveness and disrupted process of phagocytosis and chemotaxis of white blood cells, especially neutrophils (5). It is widely accepted that disordered blood glucose regulation increases mortality and morbidity, as well as hospital admission times and associated financial expenses (2,6). Blood glucose level at ICU admission was found to be a poor prognostic factor at various studies on different ICU patient populations (7-9). For example, in ICU patients admitted due to acute myocardial infarction, cardiogenic shock and need for urgent cardiac catheterization, high blood glucose levels at admission, even in non-diabetic patients, were associated with both increased in- hospital and long-term mortality (7). Among patients admitted due to acute heart failure, high admission glucose levels (above 200 mg / dL), in both diabetic and non-diabetic patients, were associated with higher mortality from cardio-vascular etiologies within one year of admission (8). Among non-diabetic patients admitted to the hospital due to acute myocardial infarction, admission glucose levels above 180 mg / dL were associated with a significant increase in all-causes in-hospital mortality (9). However, there is currently insufficient information regarding the prognostic impact of high admission glucose levels of non-diabetic septic patients admitted to the ICU (10).

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  To study the correlation between high blood glucose levels (above 180 mg / dL) upon ICU admission of non-diabetic patients with sepsis, and 28-day mortality, compared to ICU admitted septic patients with normal blood glucose levels upon admission (less than 180 mg / dL and above 70 mg / dL).

  28-day from ICU admission

Study Arms (2)

Group A- Normal ICU admission blood glucose level

Patients with admission blood glucose level lower than 180 mg / dL (but higher than 70 mg / dL).

Other: No intervention- observational study

Group B- High ICU admission blood glucose level

Patients with admission blood glucose level higher than 180 mg / dL.

Other: No intervention- observational study

Interventions

No intervention- observational study OTHER

No intervention- observational study

Group A- Normal ICU admission blood glucose level; Group B- High ICU admission blood glucose level

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-diabetic patients aged 18-99 who were admitted to the ICU between 1.1.2014 and 30.1.2020 due to sepsis or septic shock.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: December 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

IL (1)