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GLP-1 and Hyperoxia for Organ Protection in Heart Surgery

NCT02673931 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2024-08-28

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Byetta (Lilly, Exenatide)

See description of arms

DRUG

Conoxia (AGA, oxygen)

See description arms

DRUG

20% Human Albumin

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Peter Skov Olsen, MD, DMSc · Rigshospitalet, Denmark

  • Jens Christian Nilsson, MD, PhD · Rigshospitalet, Denmark

  • Lars Køber, MD, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02673931 on ClinicalTrials.gov