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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02407574
Other study ID # FFR2015
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 24, 2015
Last updated March 30, 2015
Start date May 2015

Study information

Verified date March 2015
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
External Pacing Box
Atrial pacing using an external pacing box

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Liege

Outcome

Type Measure Description Time frame Safety issue
Primary End-systolic elastane of the left ventricle. 30 minutes after CPB weaning No
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