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

Not Applicable

Recruiting

• Conditions: Glycemic Control; Critical Care; Diabetes Mellitus

• Registration Number: NCT06810596
• Lead Sponsor: Suez Canal University

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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-12-15
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time needed to achieve the target blood glucose (80-180)	up to 28 days	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.

Secondary Outcome Measures

Name	Time	Method
Assess the effect of different factors in the management of hyperglycemia in critical ill patients.	up to 28 days	Assess the effect of different factors in the management of hyperglycemia in critical ill patients (age, gender comorbidities, etc.)
Assess the incidence of hypoglycemia among the patients of both groups.	up to 28 days	Assess the incidence of hypoglycemia among the patients of both groups.
Compare Ventilator Free Days between two groups.	up to 28 days	Compare Ventilator Free Days between two groups
Compare the ICU stay and hospital stay between the two groups.	up to 28 days	Compare the ICU stay and hospital stay between the two groups.
Compare ICU and 30 days Mortality rates between the two groups.	30 days	Compare ICU and 30 days Mortality rates between the two groups.

Trial Locations

Locations (1)

Suez Canal University Hospitals; 🇪🇬 Ismailia, Egypt