Tight Intra-Operative Glucose Control During Coronary Artery Bypass Surgery

NCT ID: NCT00394303

Last Updated: 2009-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-08-31

Brief Summary

Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient outcomes in the hospital in several settings, mainly among critically ill patients hospitalized in intensive care units.

We plan to assess the importance of tight glucose control during open-heart surgery. The prevalence of hyperglycemia (elevated blood glucose) during this operation is high. Hyperglycemia may be associated with increased vulnerability to surgical site infections, neurological damage, cardiac and renal injury. Conversely, tight glucose control may be associated with hypoglycemia (pathologically low glucose levels) that may results in neurological injury. We hypothesize that tight glucose control will improve patient outcomes following surgery.

Detailed Description

Current evidence supports intensive glucose control for patients in the intensive care unit post-cardiac surgery. The risk-benefit ratio of tight glucose control using continuous insulin infusion during surgery has not been established. Pros for tight control include the association of hyperglycemia with neurological injury, cardiac ischemia, white blood cell dysfunction and renal failure. The cons include adverse effects, mainly hypoglycemia and hypokalemia. As with any intervention in medicine, tight intra-operative glucose control should be assessed in a randomized controlled trial.

Objectives:to assess whether tight intra-operative tight glucose control using continuous insulin infusion reduces morbidity and mortality following cardiac surgery, defined as the incidence rate of surgical site infections, adverse neurological events, renal failure and 30-day mortality following CABG.

Additional outcomes will include the effect of continuous insulin infusion on longer-term mortality; other infectious complications and antibiotic use during hospitalization; cardiovascular outcomes; the need for re-operations; length of hospital stay; readmission; hypoglycemia and other adverse events.

Design: randomized controlled trial, with blinding of outcome assessors.

Participants: all consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.

Exclusion criteria: patients with diabetic ketoacidosis, or hyperosmolar coma.

Intervention: Continuous insulin infusion throughout the operation aimed to maintain normoglycemia using a nomogram

Control: Glucose management according to the discretion of the anesthesiologist (continuous or bolus infusion)

During the early post-operative period (ICU-stay following surgery), all patients will be treated with intensive glucose control targeting glucose levels between 80-110.

Conditions

Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Intervention

Group Type: EXPERIMENTAL

Intraoperative continuous insulin infusion

Intervention Type: DRUG

Nomogram specified in appendix

2

Control

Group Type: NO_INTERVENTION

Control

Intervention Type: OTHER

Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels \<200 mg.dl, reflecting current practice.

Interventions

Intraoperative continuous insulin infusion

Nomogram specified in appendix

Intervention Type: DRUG

Control

Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels \<200 mg.dl, reflecting current practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All consecutive patients >18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.

Exclusion Criteria

• Patients with diabetic ketoacidosis, or hyperosmolar coma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rabin Medical Center, Beilinson Hospital

Principal Investigators

Mical Paul, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center, Beilinson Hospital

Petah Tikvah, , Israel

Countries

Israel

Other Identifiers

4214

Identifier Type: -

Identifier Source: org_study_id