NCT01813968

Brief Summary

Ischemic postconditioning by repetitive cycles of reperfusion and ischemia has been proven both in animal models and in humans. This study aims to investigate the effect of ischemic postconditioning on postoperative hemodynamic function in a standard heart surgery patient population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

5.4 years

First QC Date

March 13, 2013

Last Update Submit

December 11, 2023

Conditions

Cardiac Surgery

Keywords

Ischemic postconditioningAdult cardiac surgeryAortic valve surgerySwan-GanzCardiac index

Outcome Measures

Primary Outcomes (1)

  • Change in cardiac index between the groups during the first postoperative day

    Cardiac index is measured by a Swan-Ganz catheter inserted preoperatively

    The first postoperative day: measurements at 2, 8 and 18 hrs postoperatively

Study Arms (2)

Ischemic postconditioning

EXPERIMENTAL

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

Procedure: Ischemic postconditioning

Control

NO INTERVENTION

Standard operating technique

Interventions

Ischemic postconditioningPROCEDURE
Ischemic postconditioning

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective surgery of the ascending aorta or the aortic valve

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, Oslo University Hospital, Ullevål

Oslo, 0424, Norway

Location

MeSH Terms

Interventions

Ischemic Postconditioning

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 19, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 5, 2018

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

NO(1)