NCT00394303

Brief Summary

Blood glucose levels increase in response to stress, infection or other conditions faced by patients in the hospital. This occurs commonly among patients with known diabetes, but also among non-diabetic hospitalized patients. Tight glucose control, the maintenance of blood glucose levels within normal limits (80-120 mg/dl), has been shown to improve patient outcomes in the hospital in several settings, mainly among critically ill patients hospitalized in intensive care units. We plan to assess the importance of tight glucose control during open-heart surgery. The prevalence of hyperglycemia (elevated blood glucose) during this operation is high. Hyperglycemia may be associated with increased vulnerability to surgical site infections, neurological damage, cardiac and renal injury. Conversely, tight glucose control may be associated with hypoglycemia (pathologically low glucose levels) that may results in neurological injury. We hypothesize that tight glucose control will improve patient outcomes following surgery.

Trial Health

57
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Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 1, 2009

Status Verified

June 1, 2007

First QC Date

October 31, 2006

Last Update Submit

March 31, 2009

Conditions

Coronary Artery Bypass

Keywords

Open heart surgeryDiabetes mellitusHyperglycemiaSurgical site infectionNormoglycemia

Outcome Measures

Primary Outcomes (4)

  • 30-day all-cause mortality.

    30-day

  • Deep or organ/ space (mediastinitis) surgical site infections.

    90 days

  • Acute renal failure during post-operative ICU stay, defined as: doubling of serum creatinine from baseline; or >50% reduction from baseline glomerular filtration rate; or need for renal replacement therapy.

    30 days

  • Perioperative cerebrovascular event defined as any new, temporary or permanent, focal or global neurological deficit.

    30 days

Secondary Outcomes (12)

  • Individual components of the composite primary outcome

    30 days

  • 6-months and long-term survival.

    6 ans 12 months

  • Other infectious complications during ICU stay including pneumonia and bloodstream infections according to CDC criteria

    ICU stay

  • Antibiotic use

    30 days

  • Durations of intubation, ICU and hospital stay

    hospital stay

  • +7 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Intervention

Drug: Intraoperative continuous insulin infusion

2

NO INTERVENTION

Control

Other: Control

Interventions

Intraoperative continuous insulin infusionDRUG

Nomogram specified in appendix

1
ControlOTHER

Glucose management according to the discretion of the anesthesiologist aimed to maintain glucose levels \<200 mg.dl, reflecting current practice.

2

Eligibility Criteria

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

You may qualify if:

  • All consecutive patients \>18 years undergoing CABG, without or without additional valve or other surgery at Rabin Medical Center; Beilinson campus, providing informed consent.

You may not qualify if:

  • Patients with diabetic ketoacidosis, or hyperosmolar coma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikvah, 49100, Israel

Location

MeSH Terms

Conditions

Diabetes MellitusHyperglycemiaSurgical Wound Infection

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mical Paul, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

February 1, 2007

Study Completion

August 1, 2009

Last Updated

April 1, 2009

Record last verified: 2007-06

Locations

IL(1)