Tight Intra-Operative Glucose Control During Coronary Artery Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT00394303|
Recruitment Status : Terminated (Trial suspended on 26 February, following the publication of a trial with negative results (Ann Intern Med 146(4), 2007). Pending ethics committee re-approval.)
First Posted : November 1, 2006
Last Update Posted : April 1, 2009
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tight Intra-Operative Glucose Control Using Continuous Insulin Infusion During Coronary Artery Bypass Surgery: Randomized Controlled Trial|
|Study Start Date :||February 2007|
|Estimated Study Completion Date :||August 2009|
Drug: Intraoperative continuous insulin infusion
Nomogram specified in appendix
No Intervention: 2
Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels <200 mg.dl, reflecting current practice.
- 30-day all-cause mortality. [ Time Frame: 30-day ]
- Deep or organ/ space (mediastinitis) surgical site infections. [ Time Frame: 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. [ Time Frame: 30 days ]
- Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit. [ Time Frame: 30 days ]
- Individual components of the composite primary outcome [ Time Frame: 30 days ]
- 6-months and long-term survival. [ Time Frame: 6 ans 12 months ]
- Other infectious complications during ICU stay including pneumonia and bloodstream infections according to CDC criteria [ Time Frame: ICU stay ]
- Antibiotic use [ Time Frame: 30 days ]
- Durations of intubation, ICU and hospital stay [ Time Frame: hospital stay ]
- Other post-operative complications occurring during ICU stay, including re-intubation, re-operation [ Time Frame: 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. [ Time Frame: during surgery ]
- Occurrence of severe hypokalemia, defined as K<2.5 mEq/l, during surgery [ Time Frame: during surgery ]
- Glucose control in ICU, during the first 2 post-operative days [ Time Frame: 2 post-operative days ]
- Neurological status before surgery, at discharge and 3 months following surgery: [ Time Frame: 3 months ]
- Adverse cardiac events occurring during ICU stay [ Time Frame: ICU stay ]
- Re-hospitalizations [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394303
|Rabin Medical Center, Beilinson Hospital|
|Petah Tikvah, Israel, 49100|
|Principal Investigator:||Mical Paul, MD||Rabin Medical Center|