Completed

IPICSIschemic Postconditioning in Cardiac Surgery

What is being tested

Ischemic postconditioning

Procedure

Who is being recruted

Over 20 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2013

See protocol details

Summary

Principal SponsorOslo University Hospital

Last updated: December 15, 2023

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

Ischemic postconditioning is studied using cardiopulmonary bypass (CPB) and moderate hypothermia (32-34°C) in a patient population undergoing surgery of the aortic valve (repair/replacement ) or the ascending aorta. Postconditioning is applied by introducing reperfusion/ischemia via the cardioplegia line while the aorta is still cross-clamped thereby preventing the risk of additional neurological complications. All patients > 20 years eligible for aortic or aortic valve surgery and not affected by exclusion criteria, will be included. The study is carried out as a randomised controlled multicenter study including 5-6 heart surgery centers.

NCT01813968

Principal SponsorOslo University Hospital

Last updated: December 15, 2023

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

209 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: Patients undergoing elective surgery of the ascending aorta or the aortic valve - Exclusion Criteria: Coronary artery disease requiring bypass surgery Tricuspid valve surgery Mitral valve surgery Atrial fibrillation (permanent or paroxysmal with or without concomitant ablation procedure) Patients on per oral or parenteral steroid therapy (inhalational steroids are allowed) Patients with autoimmune diseases "Redo" operations Active endocarditis (ongoing antibiotic therapy) On the discretion of the operating surgeon or anaesthesiologist

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Ischemic postconditioning via the cardioplegia line starting with 2 min of reperfusion followed by 2 min of "ischemia" x 3

Group II

No Intervention

Standard operating technique

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål

Oslo, NorwayOpen Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål in Google Maps

CompletedOne Study Center