Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

Phase 3

Completed

• Conditions: Cardiac Surgical Procedures; Hyperglycemia

• Registration Number: NCT00282698
• Lead Sponsor: Mayo Clinic

Brief Summary

Patients with or without diabetes may have high blood sugar levels due to stress response of the body during heart surgery. This study is being done to determine if maintaining normal blood sugar levels during open-heart surgery by using intravenous insulin results in a lesser incidence of death, wound infections in the chest, disturbances of heart rhythm, kidney failure, stroke and prolonged time on the breathing machine (artificial ventilation) within 30 days after surgery.

Detailed Description

Rigorous intraoperative glycemic control may be of paramount importance in affecting outcomes after cardiac surgery. There is evidence that strict control of glucose levels postoperatively results in improved outcomes in patients undergoing cardiac surgery. There is currently no consensus on optimal management of hyperglycemia intraoperatively. The aim of this prospective randomized controlled clinical trial is to determine whether normalization of intraoperative glucose levels with insulin improves outcomes. The comparison group will be treated with current standard practice to control hyperglycemia during surgery. The primary outcome is a composite of mortality, sternal wound infections, prolonged pulmonary ventilation, cardiac arrhythmias (new-onset atrial fibrillation, heart block requiring permanent pacemaker, cardiac arrest), stroke and acute or worsening renal failure within 30 days after surgery. Secondary outcome measures are length of intensive care unit and hospital stay as well as safety and efficacy of the study insulin infusion protocol.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-27
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-20
• Last Update Posted: 2011-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiac arrhythmias
Renal failure
Mortality
Sternal wound infections
Stroke

Secondary Outcome Measures

Name	Time	Method
Lenght of intensive care unit stay
Length of hospital stay
Safety of study insulin infusion
Efficacy of study insulin infusion

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States