Tight Intra-Operative Glucose Control During Coronary Artery Bypass Surgery

Sponsor

Rabin Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00394303

Collaborator

(none)

1,400

Enrollment

Location

Arms

Duration (Months)

46.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass	Drug: Intraoperative continuous insulin infusion Other: Control	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery: Randomized Controlled Trial

Study Start Date :

Feb 1, 2007

Anticipated Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intervention	Drug: Intraoperative continuous insulin infusion Nomogram specified in appendix
No Intervention: 2 Control	Other: Control Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels <200 mg.dl, reflecting current practice.

Arm

Intervention/Treatment

Experimental: 1

Intervention

Drug: Intraoperative continuous insulin infusion

Nomogram specified in appendix

No Intervention: 2

Control

Other: Control

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

Outcome Measures

Primary Outcome Measures

30-day all-cause mortality. [30-day]
Deep or organ/ space (mediastinitis) surgical site infections. [90 days]
Acute renal failure during post-operative ICU stay, defined as: doubling of serum creatinine from baseline; or >50% reduction from baseline glomerular filtration rate; or need for renal replacement therapy. [30 days]
Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit. [30 days]

Secondary Outcome Measures

Individual components of the composite primary outcome [30 days]
6-months and long-term survival. [6 ans 12 months]
Other infectious complications during ICU stay including pneumonia and bloodstream infections according to CDC criteria [ICU stay]
Antibiotic use [30 days]
Durations of intubation, ICU and hospital stay [hospital stay]
Other post-operative complications occurring during ICU stay, including re-intubation, re-operation [ICU stay]
Occurrence of hypoglycemia, defined as blood glucose level of 50mg/ dl or less, during surgery and up to the first glucose measurement in ICU. [during surgery]
Occurrence of severe hypokalemia, defined as K<2.5 mEq/l, during surgery [during surgery]
Glucose control in ICU, during the first 2 post-operative days [2 post-operative days]
Neurological status before surgery, at discharge and 3 months following surgery: [3 months]
Adverse cardiac events occurring during ICU stay [ICU stay]
Re-hospitalizations [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.