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

NCT ID: NCT06810596

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-04-15

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.

Detailed Description

Patients will be randomized into 2 equal groups; Group 1 (SCU group) will follow the SCU protocol of Intravenous Insulin Infusion in diabetic critically ill patients Group 2 (NHS group) will follow the NHS protocol of Intravenous Insulin Infusion in critically ill diabetic patients in UK.

Randomization will be done using a web randomizer and the randomization sequence will be concealed in numbered opaque envelopes that will be opened after patient enrollment to define his or her group assignment.

In both groups, control of blood glucose will be achieved with the use of an intravenous infusion of regular insulin in saline. Insulin will be administered, reduced, or discontinued according to the protocol in the different groups.

Two nurses must check and prepare the variable rate intravenous insulin infusion (VRIII) and every time the rate of infusion is changed. Insulin must be drawn up using an insulin syringe to draw up 50 units of prescribed Human Act rapid insulin and add to 49.5 ml of 0.9% sodium chloride in a 50 ml syringe. Mix thoroughly; this will provide a concentration of 1 unit / 1 ml.

VRIII will be stopped when RBS <80mg/dl and repeat the measure of RBS after one hour.

Laboratory investigations of routine blood tests will be requested on admission and at least once daily and in case of abnormal potassium level will be measured every 6 hours.

Regarding Serum K:

If K is 3.5-5.5 mmol/l- This is the target: total K+ given should be 1.5 mmol/kg/day If K is >5.5 mmol/l - no K is to be added to the infusion fluid this day. If K is <3.5mmol/l - K+ given should be 2.0 mmol/kg/day. K+ replacement will be initiated if there are ECG changes of hypokalemia. If K is <2.5mmol/l - bolus K+ replacement 1 mEq/kg will be infused over 3 hours and serum K+ level rechecked 2 hours after the end of infusion. If recheck serum K+ level < 2.5mmol/l bolus K+ replacement will be infused again over 3 hours. If recheck serum K+ level >3mmol/l K+ maintenance will be infused 2.0 mmol/kg/day.

Data collection :

At baseline, demographic and clinical characteristics, including the Acute Physiology and Chronic Health Evaluation II (APACHE II) score and the diagnostic criteria for severe sepsis will be collected.

Medical history :

1. Medical chronic disorders and the used treatment for them, such as hypertension, diabetes, liver or renal diseases .

2. Any known allergies to the drugs to be used . laboratory investigations:

a) Daily Routine Blood test (CBC, ABG, Electrolytes). b) Prothrombin time (PT), partial tissue thromboplastin time (PTT) and International randomized ratio (INR), Liver function tests and Kidney function tests every 3 days.

c) HBA1c on admission.

Follow up:

1. Nutrition: NPO, Enteral or parental.

2. Mechanical Ventilation days.

3. Complications: DKA, Hyperglycemia or Hypoglycemia.

4. ICU Discharge Date.

5. Hospital Discharge Date.

d) Outcome: Discharge or Death.

Conditions

Glycemic Control; Critical Care; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Suez Canal University variable rate Protocol

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)

Group Type: ACTIVE_COMPARATOR

Insulin infusion protocol

Intervention Type: PROCEDURE

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

NHS group

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

Group Type: ACTIVE_COMPARATOR

Insulin infusion protocol

Intervention Type: PROCEDURE

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

Interventions

Insulin infusion protocol

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Aiman Al-Touny

Lecturer of Anesthesia and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Suez Canal University Hospitals

Ismailia, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Aiman A. Al-Touny, MD

Role: CONTACT

Aimantouny@med.suez.edu.eg

+201008185785

Mohamed E. Abdel Ghaffar, MD

Role: CONTACT

mohamed_abdelghafar@med.suez.edu.eg

+201003179831

Facility Contacts

Aiman Al-Touny, MD

Role: primary

aimantouny@med.suez.edu.eg

+201008185785

Mohamed Abdel Gaffar, MD

Role: backup

mohamed_abdelghafa@med.suez.edu.eg

+201003179831

Other Identifiers

4960#

Identifier Type: -

Identifier Source: org_study_id