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

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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

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.


Condition or disease Intervention/treatment Phase
Quality of Life Drug: Exenatide Drug: Insulin Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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.

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

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.

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 1-month mortality [ Time Frame: 1 month ]
  5. 3-months mortality [ Time Frame: 3 months ]
  6. 6-months mortality [ Time Frame: 6 month ]
  7. 12-months mortality [ Time Frame: 12 months ]
  8. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432976


Contacts
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Contact: Guillaume BESCH, M.D. +33381218958 gbesch@chu-besancon.fr

Locations
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France
Post operative intensive care unit of the cardiac surgery department Recruiting
Besançon, France, 25030
Contact: Guillaume Besch, MD       gbesch@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
AstraZeneca
Eli Lilly and Company
Investigators
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Principal Investigator: Guillaume BESCH, M.D. CHRU Besançon
Study Director: Sebastien PILI-FLOURY, M.D., PhD CHRU Besançon

Additional Information:
Publications:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02432976    
Other Study ID Numbers: 09/503
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Quality of Life
Cardiac Surgery
Coronary Artery Bypass Graft Surgery
Incretin mimetic
Exenatide
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Exenatide
Insulin Lispro
Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists