Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control
1 other identifier
interventional
250
1 country
1
Brief Summary
This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2004
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 12, 2007
CompletedFirst Posted
Study publicly available on registry
April 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 23, 2015
June 1, 2015
10.7 years
April 12, 2007
June 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
glycemic control, postoperative morbidity, inflammatory markers
24 hours following surgery
glycemic control
24 hours following surgery
Secondary Outcomes (1)
free fatty acid levels
24 hours following surgery
Study Arms (3)
B Low dose GIK
ACTIVE COMPARATORThis group will have low doses of glucose and insulin
C High Dose GIK
ACTIVE COMPARATORThis group will have high doses of insulin and glucose
A Insulin
ACTIVE COMPARATORThis group will receive only an intravenous insulin infusion
Interventions
These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.
These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl
This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl
Eligibility Criteria
You may qualify if:
- Diabetic CABG patients
You may not qualify if:
- Renal and hepatic failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (2)
Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
PMID: 37526194DERIVEDLazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H. Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients. Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4. doi: 10.1097/SLA.0b013e31822c5d78.
PMID: 21865944DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harold L Lazar MD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Cardiothoracic Surgery
Study Record Dates
First Submitted
April 12, 2007
First Posted
April 16, 2007
Study Start
July 1, 2004
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 23, 2015
Record last verified: 2015-06