Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394303
Status:
TERMINATED
Last Update Posted:
2009-04-01
First Post:
2006-10-31
Brief Title:
Tight Intra-Operative Glucose Control During Coronary Artery Bypass Surgery
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial suspended on 26 February following the publication of a trial with negative results Ann Intern Med 1464 2007 Pending ethics committee re-approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgdl 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
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
Objectivesto 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
Objectivesto 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None