NCT00282698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

10 months

First QC Date

January 26, 2006

Last Update Submit

May 20, 2011

Conditions

Cardiac Surgical ProceduresHyperglycemia

Outcome Measures

Primary Outcomes (5)

  • Mortality

  • Sternal wound infections

  • Stroke

  • Cardiac arrhythmias

  • Renal failure

Secondary Outcomes (4)

  • Lenght of intensive care unit stay

  • Length of hospital stay

  • Safety of study insulin infusion

  • Efficacy of study insulin infusion

Interventions

Insulin infusion with a goalDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects accepted for this study must be:
  • \>=18 years of age
  • Undergoing an elective cardiac surgical procedure

You may not qualify if:

  • Subjects who have one or more of the following will be excluded from the study:
  • Undergoing surgery not utilizing cardiopulmonary bypass
  • Unable to grant informed consent or comply with study procedure
  • Undergoing emergency open heart-surgery
  • \. Are allergic to any of the excipients in insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Gandhi GY, Nuttall GA, Abel MD, Mullany CJ, Schaff HV, O'Brien PC, Johnson MG, Williams AR, Cutshall SM, Mundy LM, Rizza RA, McMahon MM. Intensive intraoperative insulin therapy versus conventional glucose management during cardiac surgery: a randomized trial. Ann Intern Med. 2007 Feb 20;146(4):233-43. doi: 10.7326/0003-4819-146-4-200702200-00002.

    PMID: 17310047DERIVED

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gunjan Y. Gandhi, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

July 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

US(1)