GLP-1 and Hyperoxia for Organ Protection in Heart Surgery

Status

Status unknown

Phase

Not applicable

Enrollment

1,400 participants (actual)

Sponsor

Copenhagen University Hospital, Rigshospitalet · Other

Design

Randomized · Quadruple masking

Countries

1 country

Denmark

Start

Feb 2016

Primary completion

Sept 2024 (estimated)

Completion

Sept 2024 (estimated)

First posted

4 Feb 2016 (estimated)

Last update posted

28 Aug 2024

Conditions

Coronary Disease · Shock, Cardiogenic · Renal Failure · Stroke · Brain Injury · Aortic Valve Disease

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.

• Experimental

  GLP-1

  700 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.

• Placebo comparator

  Placebo

  20% Human Albumin is given as placebo. 700 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.

• Experimental

  Restrictive Oxygenation

  The intervention is FiO2 of 50%, given as 'Conoxia (AGA, oxygen)'. 700 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 1. a maximum of 1 hours of intervention or 2. the patient is slid from the operating table to a hospital bed for transfer to the intensive care unit, whichever comes first.

• Active comparator

  Liberal Oxygenation

  The intervention is a FiO2 of 100%, given as 'Conoxia (AGA, oxygen)'. 700 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 1. a maximum of 1 hours of intervention or 2. the patient is slid from the operating table to a hospital bed for transfer to the intensive care unit, whichever comes first.

1. Time in days to the first occurring of the following co-primary end-points throughout the follow-up period

   Time frame · Minimum 12 months

   Registry description

   1. Death from any cause or 2. Any of the following adverse events 1. Renal failure requiring any type of renal replacement therapy 2. 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 3. 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.