Comparing Efficacy Between Two Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU

NCT06810596 | Recruiting

• 1 other identifier: 4960#
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of clinical trial is to improve the adequacy of blood sugar control in diabetic critically ill adult patients who admitted to the intensive care unit(ICU) in Suez Canal University (SCU) hospitals by comparing glycemic control efficacy between the NHS in the UK and suggested SCU Protocols of Intravenous Insulin Infusion. The main questions it aims to answer are: Is SCU protocol of Intravenous Insulin Infusion more effective than NHS protocol in achieving blood glucose control targets in critically ill adult patients? Researchers will compare glycemic control efficacy between the NHS in UK and suggested SCU Protocols of Intravenous Insulin Infusion for critically ill Adults in ICU to determine the best protocol in achieving good blood glucose control in diabetic critically ill adult patients in SCU Hospitals.

Conditions

Glycemic Control; Critical Care; Diabetes Mellitus

Keywords

Glycemic Control; Insulin Infusion Protocol; Critically ill

Outcome Measures

Primary Outcomes (1)

• Time needed to achieve the target blood glucose (80-180)

  Assess the time needed to achieve the target blood glucose (80-180) in both protocols of intravenous insulin infusion in management of hyperglycemia in diabetic critically ill patients.

  up to 28 days

Secondary Outcomes (5)

• Assess the effect of different factors in the management of hyperglycemia in critical ill patients.

  up to 28 days

• Assess the incidence of hypoglycemia among the patients of both groups.

  up to 28 days

• Compare Ventilator Free Days between two groups.

  up to 28 days

• Compare the ICU stay and hospital stay between the two groups.

  up to 28 days

• Compare ICU and 30 days Mortality rates between the two groups.

  30 days

Study Arms (2)

Suez Canal University variable rate Protocol

ACTIVE COMPARATOR

Variable rate intravenous insulin infusion will be administrated according to random blood glucose and adjusted body weight (ABW). ABW = IBW + 0.33x (actual body weight - IBW) If the RBS level is 80 - 200 mg/dl, the Insulin infusion rate = RBS/ 100, and for insulin-sensitive patients = RBS/150 If the RBS level is 201 - 250 mg/dl, the Insulin infusion rate = RBS/ 80, and for insulin-sensitive patients = RBS/80 If the RBS level is 251 - 300 mg/dl, the Insulin infusion rate = RBS/ 60, and for insulin-sensitive patients = RBS/60 If the RBS level \> 300 mg/dl, the Insulin infusion rate = 0.1 ml /kg/h adjusted body weight (Max: 10 unit/h)

Procedure: Insulin infusion protocol

NHS group

ACTIVE COMPARATOR

If the RBS level is 72- 144 mg/dl, the Insulin infusion rate = 1 ml/hr, for insulin-sensitive patients 0.5 ml/hr, and for Insulin resistance patients = 2 ml/hr If the RBS level is 145- 216mg/dl, the Insulin infusion rate = 2 ml/hr, for insulin-sensitive patients 1 ml/hr, and for Insulin resistance patients = 4 ml/hr If the RBS level is 217- 288 mg/dl, the Insulin infusion rate = 4 ml/hr, for insulin-sensitive patients 2 ml/hr, and for Insulin resistance patients = 6 ml/hr If the RBS level is 289- 360 mg/dl, the Insulin infusion rate = 5 ml/hr, for insulin-sensitive patients 3 ml/hr, and for Insulin resistance patients = 7 ml/hr If the RBS level is 361- 432 mg/dl, the Insulin infusion rate = 6 ml/hr, for insulin-sensitive patients 4 ml/hr, and for Insulin resistance patients = 8 ml/hr If the RBS level is \>433 mg/dl, the Insulin infusion rate = 8 ml/hr, for insulin-sensitive patients 6 ml/hr, and for Insulin resistance patients = 10 ml/hr

Procedure: Insulin infusion protocol

Interventions

Insulin infusion protocol PROCEDURE

comparing the efficacy of 2 different protocols for glycemic control in diabetic critically ill patients.

NHS group; Suez Canal University variable rate Protocol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who admitted to the hospital with a potentially life-threatening condition (Critically ill patients) with HbA1C \>6.0.

You may not qualify if:

• DKA patients.
• Pregnant or breast-feeding patients.
• Hyperosmolar Non-Ketotic Coma.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University Hospitals

Ismailia, 41522, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Critical Illness

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aiman A. Al-Touny, MD

CONTACT

+201008185785; Aimantouny@med.suez.edu.eg

Mohamed E. Abdel Ghaffar, MD

CONTACT

+201003179831; mohamed_abdelghafar@med.suez.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 5, 2025
• Study Start: December 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 15, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 months and ending 36 months following article publication.
• Access Criteria: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

Locations

EG (1)