Assessment of the Force Frequency Relationship of the Myocardium After On-pump CABG Surgery

March 30, 2015 updated by: Jean François Brichant, University of Liege
The aim of the study is to determine whether increasing the heart rate by epicardial atrial pacing after surgery improves the contractile force of the myocardium. After complete weaning from CPB, several pressure-loops of the LV will be recorded at different levels of preload using transoesophageal echo, invasive blood pressure monitoring. The preload will be manipulated by adding fluid from the CPB reservoir or draining fluid into the CPB reservoir.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CABG only surgery
  • Preopeartive LVEF ≥ 53 %
  • Use of epicardial pacing wires to assist CPB weaning

Exclusion Criteria:

  • Contra-indication to TEE
  • AV block at the time of CPB weaning
  • Sinus rhythm less than 50 or more than 90 BPM after CPB weaning.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spontaneous rhythm first
Stepwise preload increase by repeated administration of 100 mL of fluid during spontaneous rhythm and then stepwise preload reduction by repeated drainage of 100 mL of fluid during atrial pacing.
Device: External Pacing Box
Atrial pacing using an external pacing box
Experimental: Atrial pacing first
Stepwise preload increase by repeated administration of 100 mL of fluid during atrial pacing and then stepwise preload reduction by repeated drainage of 100 mL of fluid during spontaneous rhythm.
Device: External Pacing Box
Atrial pacing using an external pacing box

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
End-systolic elastane of the left ventricle.
Time Frame: 30 minutes after CPB weaning
30 minutes after CPB weaning

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • FFR2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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