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Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients (ExeQOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432976
Recruitment Status : Unknown
Verified May 2015 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : May 4, 2015
Last Update Posted : May 8, 2015
Sponsor:
Collaborators:
AstraZeneca
Eli Lilly and Company
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date  ICMJE April 29, 2015
First Posted Date  ICMJE May 4, 2015
Last Update Posted Date May 8, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
Variation of the SF-36 score value at 3-months [ Time Frame: 3 months ]
The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life. The use of the SF-36 score is recommended by the French Health Authority in coronary patients. The variation of the SF-36 score value at 3-months is defined as the difference between the SF36-score value at 3 months minus the preoperative SF-36 score value.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2015)
  • Variation of the SF-36 score value at 1-month [ Time Frame: 1 month ]
    The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life. The use of the SF-36 score is recommended by the French Health Authority in coronary patients. The variation of the SF-36 score value at 1-month is defined as the difference between the SF36-score value at 1 month minus the preoperative SF-36 score value.
  • Variation of the SF-36 score value at 6-months [ Time Frame: 6 months ]
    The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life. The use of the SF-36 score is recommended by the French Health Authority in coronary patients. The variation of the SF-36 score value at 6-months is defined as the difference between the SF36-score value at 6 months minus the preoperative SF-36 score value.
  • Variation of the SF-36 score value at 12-months [ Time Frame: 12 months ]
    The SF-36 score is a self-administered questionnaire that assess both the physical and the psychosocial health-related quality of life. The use of the SF-36 score is recommended by the French Health Authority in coronary patients. The variation of the SF-36 score value at 12-months is defined as the difference between the SF36-score value at 12 months minus the preoperative SF-36 score value.
  • 1-month mortality [ Time Frame: 1 month ]
  • 3-months mortality [ Time Frame: 3 months ]
  • 6-months mortality [ Time Frame: 6 month ]
  • 12-months mortality [ Time Frame: 12 months ]
  • Postoperative left ventricular function [ Time Frame: Day 7 ]
    Left ventricular function will be assessed during a transthoracic echocardiography performed at Day 7. Left ventricular ejection fraction and filling pressure will be measured during this procedure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients
Official Title  ICMJE Impact of Intravenous Exenatide Versus Insulin on Quality of Life in Cardiac Surgery Patients: an Ancillary Study of the ExSTRESS Phase II/III Clinical Trial
Brief Summary

A diminution of quality of life is often reported by patients after coronary artery bypass graft (CABG) surgery. A part of this diminution could be explain by postoperative left ventricular (LV) dysfunction.

Exenatide (Byetta®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. Recent data have suggested that exenatide could improve LV function by an inotropic effect in patients suffering from cardiogenic shock or from congestive heart failure. Moreover, patients suffering from congestive heart failure reported a better quality of life when they were treated with exenatide compared to placebo.

The investigators hypothesize that perioperative exenatide infusion could improve postoperative quality of life in CABG surgery patients.

Detailed Description

The ExeQOL study is an ancillary study of the ExSTRESS trial (www.clinicaltrials.gov identifier: NCT01969149).

The ExSTRESS trial is a phase II/III randomized-controlled trial that aim at assessing intravenous exenatide versus insulin for perioperative glycemic control in CABG surgery.

The phase II of the ExStress trial will assess the safety and the efficacy of a continuous intravenous infusion of exenatide for the management of post operative stress hyperglycemia after planned coronary artery graft bypass (CABG) surgery.

The aim of the phase III of the ExSTRESS trial is to compare the efficacy of a continuous intravenous infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of short-acting insulin, for the management of post operative stress hyperglycemia after planned CABG surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Quality of Life
Intervention  ICMJE
  • Drug: Exenatide

    Exenatide. Exenatide: bolus of 0.05 µg/min infused during the 1st hour of treatment, followed by a continuous infusion of 0.025 µg/min until the end of treatment.

    The exenatide therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured. A of exenatide will be intravenously .

    The treatment will be administrated during the first postoperative 48 hours in the intensive care unit or until intensive care unit discharge if this event occurs earlier.

    Other Names:
    • Byetta
    • Exendin-4
    • Incretin
  • Drug: Insulin

    Insulin: Humalog (insulin lispro human analog). The insulin therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured.

    The dose of insulin intravenously infused will be adapted to blood glucose measurements, following the insulin therapy protocol used in our department.

    The insulin therapy protocol used in our department and prescribed as the benchmark treatment in the present study has been validated in a previous study. It has been derived from the protocol validated by Goldberg et al.

    Other Names:
    • Humalog
    • Insulin Lispro
    • Human Analog
Study Arms  ICMJE
  • Experimental: Exenatide group

    Exenatide. Exenatide: bolus of 0.05 µg/min infused during the 1st hour of treatment, followed by a continuous infusion of 0.025 µg/min until the end of treatment.

    The exenatide therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured. A of exenatide will be intravenously .

    The treatment will be administrated during the first postoperative 48 hours in the intensive care unit or until intensive care unit discharge if this event occurs earlier.

    Intervention: Drug: Exenatide
  • Active Comparator: Insulin group

    Insulin: Humalog (insulin lispro human analog). The insulin therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured.

    The dose of insulin intravenously infused will be adapted to blood glucose measurements, following the insulin therapy protocol used in our department.

    The insulin therapy protocol used in our department and prescribed as the benchmark treatment in the present study has been validated in a previous study. It has been derived from the protocol validated by Goldberg et al.

    Intervention: Drug: Insulin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 1, 2015)
544
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age over 18.
  • Patient consent.
  • Non insulin requiring type 2 diabetic patients.
  • Non diabetic patients.
  • Planned coronary artery bypass graft (CABG) surgery.
  • ASA (American Society of Anesthesiologists) score 1, 2, or 3.

Exclusion Criteria:

  • Pregnancy and breast feeding.
  • Pancreatectomy.
  • Acute pancreatitis.
  • Chronic pancreatitis.
  • Type 1 diabetic patients.
  • Insulin requiring type 2 patients.
  • HbA1c>8%
  • Ketoacidosis.
  • Hyperosmolar coma.
  • Preoperative blood glucose level above 300 mg/dl [21].
  • Insulin or exenatide contraindication.
  • History of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min.
  • Emergency surgery.
  • Planned non CABG cardiac surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02432976
Other Study ID Numbers  ICMJE 09/503
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE
  • AstraZeneca
  • Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Guillaume BESCH, M.D. CHRU Besançon
Study Director: Sebastien PILI-FLOURY, M.D., PhD CHRU Besançon
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP