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

NCT02432976 | Completed Phase 2 DMC

• 1 other identifier: 09/503
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

Quality of Life; Cardiac Surgery; Coronary Artery Bypass Graft Surgery; Incretin mimetic; Exenatide

Outcome Measures

Primary Outcomes (1)

• Variation of the SF-36 score value at 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.

  3 months

Secondary Outcomes (8)

• Variation of the SF-36 score value at 1-month

  1 month

• Variation of the SF-36 score value at 6-months

  6 months

• Variation of the SF-36 score value at 12-months

  12 months

• 1-month mortality

  1 month

• 3-months mortality

  3 months

Study Arms (2)

Exenatide group

EXPERIMENTAL

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

Insulin group

ACTIVE COMPARATOR

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

Interventions

Exenatide DRUG

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.

Also known as: Byetta, Exendin-4, Incretin

Exenatide group

Insulin DRUG

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.

Also known as: Humalog, Insulin Lispro, Human Analog

Insulin group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• AstraZeneca: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Post operative intensive care unit of the cardiac surgery department

Besançon, 25030, France

Location

Related Publications (5)

• Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7. doi: 10.1053/j.jvca.2004.08.003.

  PMID: 15650975 BACKGROUND

• Studer C, Sankou W, Penfornis A, Pili-Floury S, Puyraveau M, Cordier A, Etievent JP, Samain E. Efficacy and safety of an insulin infusion protocol during and after cardiac surgery. Diabetes Metab. 2010 Feb;36(1):71-8. doi: 10.1016/j.diabet.2009.05.008. Epub 2010 Jan 25.

  PMID: 20097589 BACKGROUND

• Perneger TV, Leplege A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60. doi: 10.1016/0895-4356(94)00227-h.

  PMID: 7775992 BACKGROUND

• Sokos GG, Nikolaidis LA, Mankad S, Elahi D, Shannon RP. Glucagon-like peptide-1 infusion improves left ventricular ejection fraction and functional status in patients with chronic heart failure. J Card Fail. 2006 Dec;12(9):694-9. doi: 10.1016/j.cardfail.2006.08.211.

  PMID: 17174230 BACKGROUND

• Sokos GG, Bolukoglu H, German J, Hentosz T, Magovern GJ Jr, Maher TD, Dean DA, Bailey SH, Marrone G, Benckart DH, Elahi D, Shannon RP. Effect of glucagon-like peptide-1 (GLP-1) on glycemic control and left ventricular function in patients undergoing coronary artery bypass grafting. Am J Cardiol. 2007 Sep 1;100(5):824-9. doi: 10.1016/j.amjcard.2007.05.022. Epub 2007 Jun 14.

  PMID: 17719327 BACKGROUND

Related Links

• Link to ExStress Study protocol

MeSH Terms

Interventions

Exenatide; Incretins; Insulin; Insulin Lispro; purine-analog-sensitive kinase, human

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Insulin, Short-Acting

Study Officials

• Guillaume BESCH, M.D.

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Sebastien PILI-FLOURY, M.D., PhD

  CHRU Besançon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 4, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 9, 2021

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)