AzTrials
AzTrials

Stress HyperglycemiaPhase 2/3ExSTRESSNCT01969149

Exenatide for Stress Hyperglycemia

A Phase 2/3 study testing Exenatide and Insulin in people with Stress Hyperglycemia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients. It has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Stress Hyperglycemia
What is being tested?
Exenatide and Insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteFrance
Study dates
Jan 2015to Dec 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnancy and breast feeding.
  • Pancreatectomy.
  • Acute pancreatitis.
  • Chronic pancreatitis.
  • Type 1 diabetic patients.
  • Insulin requiring type 2 patients.
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Post operative intensive care unit of the cardiac surgery department

    Besançon, 25030

Other trials in France

About this study

Official title: Intravenous Exenatide (Byetta®) Versus Insulin for Perioperative Glycemic Control in Cardiac Surgery: the Open-labeled Randomized Phase II/III ExStress Study

Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients.

It has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity.

Read more

The Leuven et al.'s study suggested that strict glycemic perioperative control using an intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's patients. This study included a majority of cardiac surgery patients. Others studies have suggested that the beneficial effect of insulin-based tight perioperative glycemic control might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain perioperative glycemic stability in most patients.

Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level.

We hypothesize that continuous intravenous infusion of exenatide could improve perioperative glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared to a conventional insulin therapy during the perioperative period of cardiac surgery.

Read the detailed description

The phase II of the study 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.

A nested cohort study will concern the 24 first patients included in the study (12 patients/group) to assess the impact of a continuous intravenous infusion of exenatide on post operative glycemic variability after planned CABG surgery.

The aim of the phase III of the study will 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.

Being tested
Exenatide, Insulin
Keywords
Stress Hyperglycemia, Perioperative glycemic control, Cardiac surgery, Coronary artery bypass surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExenatideDrug

    Also called Byetta, Exendin-4, Incretin

  • InsulinDrug

    Also called Humalog Insulin Lispro Human Analog

Study groups in NCT01969149
Study groupRoleWhat they receive
Exenatide groupExperimentalExenatide. 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.
Receives: Drug: Exenatide
Insulin groupActive comparatorInsulin: 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.
Receives: Drug: Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients spending more than 50 % of the time in the glycemic target range (100 to 140 mg/dl)

    The percentage of time spent achieving blood glucose control is defined as the ratio between the total time spent achieving blood glucose control and the total time under treatment.

    Blood glucose measurement will be done hourly. Blood glucose control is considered to be achieved between 2 blood glucose measurements if the first blood glucose value measured belongs to blood glucose target interval, defined as blood glucose level between 100 mg/dl l and 140 mg/dl l.

    Measured: 48 hours

Secondary outcomes (13)

  1. Hypoglycemia

    Hypoglycemia is defined as blood glucose level less than 80 mg/dl.

    Measured: 48 hours

  2. Severe hypoglycemia

    Severe hypoglycemia is defined as blood glucose level less than 40 mg/dl.

    Measured: 48 hours

  3. Number of patients needing rescue to insulin therapy protocol

    Measured: 48 hours

  4. Number of adverse events occuring in the exenatide group

    As the safety of exenatide has never been assessed in the perioperative period in cardiac surgery, all adverse events will be reported, in particular: known adverse events (diarrhea, nausea, vomiting) et severe adverse events (pancreatitis, acute renal failure, death, cardiac arrest).

    Measured: Day 30

  5. Mortality

    Measured: Day 30

  6. Postoperative morbidity

    Postoperative morbidity is defined as:

    • neurological complications: stroke.
    • renal complication: acute renal failure requiring dialysis.
    • cardiac complication: cardiogenic shock, arrhythmia, myocardial infarct.
    • vasopressive drug support in postoperative intensive care unit.
    • length of postoperative mechanical ventilation.
    • infectious complication: deep sternal infection.

    Measured: Day 30

  7. The mean (GluAve) and standard deviation (GluSD) of blood glucose

    Measured: 48 hours

  8. The coefficient of variability (GluCV) of blood glucose level

    GluCV = GluSD*100/GluAve

    Measured: 48 hours

  9. Mean number of blood glucose measured

    Measured: 48 hours

  10. Mean difference between each blood glucose measurement and 120 mg/dl

    Measured: 48 hours

  11. Perioperative cardiac mortality

    Measured: Day 30

  12. Perioperative non cardiac mortality

    Measured: Day 30

  13. Length of stay in intensive care unit

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2013 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01969149
Sponsor's protocol ID
API/2009/10
Acronym
ExSTRESS
Status last verified
Mar 2016
First submitted
15 Oct 2013
Last updated
6 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15650975

  • 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.

    PubMed 20097589

  • Galiatsatos P, Gibson BR, Rabiee A, Carlson O, Egan JM, Shannon RP, Andersen DK, Elahi D. The glucoregulatory benefits of glucagon-like peptide-1 (7-36) amide infusion during intensive insulin therapy in critically ill surgical patients: a pilot study. Crit Care Med. 2014 Mar;42(3):638-45. doi: 10.1097/CCM.0000000000000035.

    PubMed 24247476

  • Besch G, Perrotti A, Salomon du Mont L, Puyraveau M, Ben-Said X, Baltres M, Barrucand B, Flicoteaux G, Vettoretti L, Samain E, Chocron S, Pili-Floury S. Impact of intravenous exenatide infusion for perioperative blood glucose control on myocardial ischemia-reperfusion injuries after coronary artery bypass graft surgery: sub study of the phase II/III ExSTRESS randomized trial. Cardiovasc Diabetol. 2018 Nov 1;17(1):140. doi: 10.1186/s12933-018-0784-y.

    PubMed 30384842

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Exenatide and Insulin in people with Stress Hyperglycemia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients spending more than 50 % of the time in the glycemic target range (100 to 140 mg/dl) (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01969149, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in