Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses Will Provide Valuable Information on the Optimal Method for Achieving Blood Glucose Control Intraoperatively.

NCT07056088 | Not Yet Recruiting DMC

• 1 other identifier: IRB # 2023-45
• Study Type: interventional
• Target: 384
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiac surgery patients often experience elevated blood glucose levels, which can lead to poor surgical outcomes and increased postoperative complications. Therefore, tight blood glucose control during surgery is important. Currently, there is no consensus on the best method for blood glucose control during cardiac surgery. This proposal aims to perform a randomized controlled trial to compare blood glucose control intraoperatively using an insulin drip versus insulin boluses. The primary objective of the study is to compare blood glucose control intraoperatively between patients who receive insulin drip and patients who receive insulin boluses during adult cardiac surgery. This study will be a randomized controlled trial in which adult patients undergoing cardiac surgery will be randomized into two groups: insulin drip and insulin boluses. Patients with a history of diabetes or those currently taking antidiabetic medications will be included in the study. This randomized controlled trial will provide valuable information on the optimal method for achieving blood glucose control intraoperatively. The results of this study may help improve patient outcomes and reduce the incidence of postoperative complications.

Conditions

Hypoglycemia (Diabetic)

Outcome Measures

Primary Outcomes (1)

• Rate of severe hypoglycemia

  one year

Secondary Outcomes (3)

• Duration of ICU stay

  24 hours

• The incidence of wound infection

  7-30 days

• lactate clearance

  From the end of surgery to 6 hours postoperatively

Study Arms (2)

Insulin drip

EXPERIMENTAL

Drug: Insulin Drip Therapy

Insulin boluses

OTHER

Control group

Drug: Insulin boluses

Interventions

Insulin Drip Therapy DRUG

Simple randomization will be used for randomization. The participants will be randomized into two groups based on methods of insulin delivery. * Group A: Insulin drip will be administered at a starting rate of 2 units/hour and titrated to maintain blood glucose levels between 80-180 mg/dL. * Group B: Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL. Insulin boluses will be considered as a control group.

Insulin drip

Insulin boluses DRUG

Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL. Insulin boluses will be considered as a control group

Insulin boluses

Eligibility Criteria

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

You may qualify if:

• All adult patients (above 18 y of age undergoing Cardiac surgery with preoperative blood glucose level (80 -180 mg/dL)
• Patient with History of diabetes and those taking antidiabetics medications.

You may not qualify if:

• Patients with known allergy or insulin intolerance.
• Patients with severe hepatic Dysfunction.
• Patient with History of hypoglycemic events in the past 6 month prior to surgery.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Simple randomization will be used for randomization. The participants will be randomized into two groups based on methods of insulin delivery. * Group A: Insulin drip will be administered at a starting rate of 2 units/hour and titrated to maintain blood glucose levels between 80-180 mg/dL. * Group B: Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL. Insulin boluses will be considered as a control group.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 9, 2025

Record last verified: 2025-07