NCT02407574

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 24, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

March 24, 2015

Last Update Submit

March 30, 2015

Conditions

Adult Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • End-systolic elastane of the left ventricle.

    30 minutes after CPB weaning

Study Arms (2)

Spontaneous rhythm first

EXPERIMENTAL

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 first

EXPERIMENTAL

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

Interventions

External Pacing BoxDEVICE

Atrial pacing using an external pacing box

Atrial pacing firstSpontaneous rhythm first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 3, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-03