Tight Intra-Operative Glucose Control During Coronary Artery Bypass Surgery

Coronary Artery Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00394303
• Other study ID #: 4214
• Status: Terminated
• Phase: Phase 4
• First received: October 31, 2006
• Last updated: March 31, 2009
• Start date: February 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2007
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1400
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

Drug:
• Intraoperative continuous insulin infusion
Nomogram specified in appendix

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

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson Hospital	Petah Tikvah

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day all-cause mortality.		30-day	Yes
Primary	Deep or organ/ space (mediastinitis) surgical site infections.		90 days	No
Primary	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	Yes
Primary	Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit.		30 days	Yes
Secondary	Individual components of the composite primary outcome		30 days	Yes
Secondary	6-months and long-term survival.		6 ans 12 months	Yes
Secondary	Other infectious complications during ICU stay including pneumonia and bloodstream infections according to CDC criteria		ICU stay	No
Secondary	Antibiotic use		30 days	No
Secondary	Durations of intubation, ICU and hospital stay		hospital stay	No
Secondary	Other post-operative complications occurring during ICU stay, including re-intubation, re-operation		ICU stay	Yes
Secondary	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	Yes
Secondary	Occurrence of severe hypokalemia, defined as K<2.5 mEq/l, during surgery		during surgery	Yes
Secondary	Glucose control in ICU, during the first 2 post-operative days		2 post-operative days	No
Secondary	Neurological status before surgery, at discharge and 3 months following surgery:		3 months	No
Secondary	Adverse cardiac events occurring during ICU stay		ICU stay	Yes
Secondary	Re-hospitalizations		30 days	No