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Outcomes With Tight Control of Hyperglycemia in Cardiac Surgery Patients

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00282698
Enrollment
400
Registered
2006-01-27
Start date
2004-07-31
Completion date
2005-05-31
Last updated
2011-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgical Procedures, Hyperglycemia

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.

Interventions

DRUGInsulin infusion with a goal

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Renal failure
Mortality
Sternal wound infections
Stroke
Cardiac arrhythmias

Secondary

MeasureTime frame
Efficacy of study insulin infusion
Lenght of intensive care unit stay
Length of hospital stay
Safety of study insulin infusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026