GLP-1 and Hyperoxia for Organ Protection in Heart Surgery (GLORIOUS)
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|ClinicalTrials.gov Identifier: NCT02673931|
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : April 17, 2018
Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain and kidneys.
This study is designed as a 2-by-2 randomized clinical trial with the purpose of investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from cardio-pulmonary bypass.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Shock, Cardiogenic Renal Failure Stroke Brain Injury Aortic Valve Disease||Drug: Byetta (Lilly, Exenatide) Drug: Conoxia (AGA, oxygen) Drug: 20% Human Albumin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1080 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Glucagon-like-peptide-1 Agonists and Restrictive vs. Liberal FiO2 in Patients Undergoing Coronary Artery Bypass Grafting or Aortic Valve Replacement - a 2-by-2 Factorial Designed, Randomized Clinical Study|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
270 patients will be randomized to GLP-1, that will be administered as follows:
248.5 mL of isotonic sodium chloride added 1.5 mL of 20% human albumin added 25 microg Byetta (Lilly, Exenatide).
The study drug infusion is initiated immediately before open heart surgery and ended after 6 hours and 15 minutes. A set dose of 17.4 microg will be given.
Drug: Byetta (Lilly, Exenatide)
See description of arms
Other Name: GLP-1 agonist
Placebo Comparator: Placebo
20% Human Albumin is given as placebo. 270 patients will be randomized to placebo, that will be administered as follows:
248.5 mL of isotonic sodium chloride added 1.5 mL of 20% human albumin.
The placebo infusion is initiated immediately before open heart surgery and ended after 6 hours and 15 minutes at the same rate as the study drug.
Drug: 20% Human Albumin
Other Name: Albumin
Experimental: Restrictive Oxygenation
The intervention is FiO2 of 50%, given as 'Conoxia (AGA, oxygen)'. 270 patients will be randomized to a FiO2 of 50% as long as the arterial O2 saturation (Sa02) remains above 91% during cardiopulmonary bypass, when weaning from and the following hour after weaning from cardiopulmonary bypass. The oxygenation strategy is discontinued and the patient is treated at the discretion of the attending physician after
Drug: Conoxia (AGA, oxygen)
See description arms
Other Name: Oxygen
Active Comparator: Liberal Oxygenation
The intervention is a FiO2 of 100%, given as 'Conoxia (AGA, oxygen)'. 270 patients will be randomized to a FiO2 of 100% during cardiopulmonary bypass, when weaning from and the following hour after weaning from cardiopulmonary bypass. The oxygenation strategy is discontinued and the patient is treated at the discretion of the attending physician after
Drug: Conoxia (AGA, oxygen)
See description arms
Other Name: Oxygen
- The presence of a co-primary end-point [ Time Frame: 24 months ]
- Death from any cause or
Any of the following adverse events
- Renal failure requiring any type of renal replacement therapy
- Stroke, defined as persisting (>24 hours) of any neurological sign or symptom of neurological dysfunction as determined by the treating physician based on available clinical information or CT-scan
- New onset/worsening heart failure defined as need for mechanical circulatory support at the ICU, inability to close the sternotomy due to post-surgical hemodynamic instability and/or persistent (> 48 hours from initiation of first surgical procedure after randomization) need for inotropic hemodynamic support. In addition admission for heart failure during follow-up following discharge from the index admission.
- Time in days to the occurrence of individual end-points [ Time Frame: 24 months ]
- Time to death from any cause, or
- Time to death or stroke, or
- Time to death or renal dysfunction requiring dialysis, or
- Time to death or new hospitalization for heart failure during follow-up following discharge from the index admission, or
- Time to death or new onset/worsening in-hospital heart failure.
- Incidence of adverse events [ Time Frame: 12 months ]
The rates of any of the adverse events:
- Surgical site infections with prolonged need (>48 h) for antibiotics, surgical intervention and/or endocarditis within 6 months of surgery, or
- Doubling of S-creatinine or decreased urine output <0.5ml/kg/h for 12 h or more at any timepoint during index admission, or
- Reduction of left ventricular ejection fraction (LVEF) of 50% (relative) compared to baseline at any time point during index admission, or
- Reoperation for bleeding, or
- Reoperation for any cause, or
- Post surgery myocardial infarction (MI) (Type 5 MI according to the Third International definition of Myocardial Infarction.), or
- Readmission for cardiovascular causes within 12 months of index surgery.
- Change in Cerebral Performance Category (CPC) [ Time Frame: 24 months ]Change from baseline in CPC-score
- Change in modified Rankin Scale (mRS) [ Time Frame: 24 months ]Change from baseline in mRS
- Change in self perceived function "two simple questions" [ Time Frame: 6 months ]'Two simple questions' at 6 months follow-up.
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): NCT02673931
|Contact: Lars Køber, MD, DMSc||Lars.Koeber@regionh.dk|
|Contact: Jesper Kjaergaard, MD, DMScemail@example.com|
|Rigshospitalet - Copenhagen University Hospital||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Jens C Nilsson, MD, PhD Jens.Christian.Nilsson@regionh.dk|
|Study Director:||Peter Skov Olsen, MD, DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Jens Christian Nilsson, MD, PhD||Rigshospitalet, Denmark|
|Study Chair:||Lars Køber, MD, DMSc||Rigshospitalet, Denmark|