NCT00646438

Brief Summary

Standard care for patients with diabetes having CABG surgery at Providence St. Vincent Medical Center includes strict control of blood sugar (glucose) levels for 3 days after surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin continuously through a needle into a vein (intravenously). This intensive glucose control has resulted in fewer complications such as serious infections and death, and has shortened the length of the hospital stay for patients. This study treatment is different from standard treatment in that it extends the intensive glucose control beyond the third postoperative day to one full year. Once discharged from the hospital following the CABG procedure, the intense glucose control is done using subcutaneous insulin (a shot under the skin), oral medications, and by measuring blood sugar levels frequently. The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year. Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 4, 2009

Status Verified

March 1, 2008

Enrollment Period

2.9 years

First QC Date

March 25, 2008

Last Update Submit

February 3, 2009

Conditions

DiabetesCoronary Artery Disease

Keywords

DiabetesCABG

Outcome Measures

Primary Outcomes (1)

  • The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year.

    3 years

Secondary Outcomes (1)

  • Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.

    3 Years

Study Arms (2)

1

ACTIVE COMPARATOR

strict glucose control (study arm)

Drug: Strict Glycemic Control for one year post-op CABG

2

NO INTERVENTION

standard insulin treatment (control arm)

Interventions

Strict Glycemic Control for one year post-op CABGDRUG

The CDE and Study Coordinator will also meet with the patient in the hospital to show how the Lifescan One-Touch Ultra II glucometer works and review the study follow-up schedule. Patients will be sent home with the Lifescan One-Touch Ultra II glucometer and a supply of strips. Post-Discharge Period Patients will meet alternatively with the CDE and study doctor on a specific schedule including every week for the first month, every 2 weeks in the second month, and every month thereafter till the 12th month. During these sessions the BG records will be downloaded from the Lifescan One-Touch Ultra II glucometer and reviewed to see patterns and any areas that could be improved or changed. For all patients in the study arm, the medications that are being taken and the results of glucose monitoring charts will be reviewed weekly with endocrinologists so that any additional recommendations may be made to improve glucose control.

Also known as: USCDP, Portlan Protocol
1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 - 80 years old
  • Pre-op diagnosis of diabetes
  • Scheduled for elective or urgent CABG surgery
  • Able to sign informed consent for research study

You may not qualify if:

  • Patients less than 18 years old or greater than 80 years old
  • Emergent or salvage CABG surgery
  • Other surgical intervention planned in same setting ( Valve surgery, TMR, MAZE...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Anthony Furnary, MD

    Providence Heart & Vascular Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M. Johnson, BA/CCRC

CONTACT

503-216-2075eric.johnson@providence.org

Tony Furnary, MD

CONTACT

503-297-1419tfurnary@mac.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

March 1, 2009

Primary Completion

February 1, 2012

Study Completion

December 1, 2012

Last Updated

February 4, 2009

Record last verified: 2008-03

Locations

US(1)