Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

Hyperglycemia Clinical Trial

Official title:

Outcomes With Use Of Intensive Insulin Therapy In Intraoperative Management Of Hyperglycemia In Adult Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282698
• Other study ID #: 322-04
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2006
• Last updated: May 20, 2011
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

All subjects accepted for this study must be:

1. >=18 years of age

2. Undergoing an elective cardiac surgical procedure

Exclusion Criteria

Subjects who have one or more of the following will be excluded from the study:

1. Undergoing surgery not utilizing cardiopulmonary bypass

2. Unable to grant informed consent or comply with study procedure

3. Undergoing emergency open heart-surgery

3. Are allergic to any of the excipients in insulin

Study Design

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

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Hyperglycemia

Intervention

Drug:
• Insulin infusion with a goal

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality
Primary	Sternal wound infections
Primary	Stroke
Primary	Cardiac arrhythmias
Primary	Renal failure
Secondary	Lenght of intensive care unit stay
Secondary	Length of hospital stay
Secondary	Safety of study insulin infusion
Secondary	Efficacy of study insulin infusion