Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03926910 |
| Other study ID # |
2018/13 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 22, 2019 |
| Est. completion date |
October 14, 2020 |
Study information
| Verified date |
November 2021 |
| Source |
CMC Ambroise Paré |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to validate a ventricular pacing test as a predictor of preload
dependency in post cardiac surgery patients.
Description:
In the immediate postoperative period of cardiac surgery and in intensive care unit (ICU), a
systemic arterial hypotension is frequently observed. This hypotension is often due to
hypovolemia but also to pump dysfunction and/or vasoplegia. Early recognition of the
hypotensive mechanism is necessary because it requires immediate specific treatment.
The interest of a vascular filling is usually estimated by a preload dependence test (fluid
responsiveness), showing an increase in the stroke volume when preload is increased according
to the Starling the law of the heart. To date, a preload dependency test is usually performed
by passive leg raise (PLR) or by measuring the respiratory pulse variation (ΔPP).
The PLR response varies according to the legs venous volume and capacitance. The derivation
of ΔPP has been validated in patients intubated, sedated, and ventilated in standard
conditions, in sinus rhythm but the ΔPP directly displayed by the monitors is unreliable and
the manual calculation on pressure curve is fastidious. Faced with these difficulties, the
trend is to realize a blind filling with physiologic saline solution and to judge his
interest on clinical and / or hemodynamic criteria.
After cardiac surgery, ventricular epicardial electrodes are systematically placed allowing a
temporary stimulation by an external pacemaker in case of postoperative atrio-ventricular
blocks. The ventricular stimulation without atrial pacing (VESAP) leads to a loss of the
atrial systole and therefore a decrease in the left ventricular preload. During the
functional test of epicardial electrodes at a frequency greater than the patient's, it is
possible to observe in certain circumstances a decrease of the arterial blood pressure, but
of varying importance.
The investigators suspect that the eventual fall in blood pressure during a ventricular
pacing test, could be correlated with preload dependence. Therefore, investigator hypothesize
that ventricular pacing can be used to realize a functional testing of preload dependence,
easy to achieve. Indeed, if doctors admit that during a brief ventricular stimulation, heart
rate and systemic vascular resistance remain unchanged, the drop in blood pressure should
reflect the decrease in stroke volume.
The main objective of this study is to demonstrate that the response to VESAP can predict the
preload dependence of patients after a cardiac surgery. The primary endpoint will study the
predictive value of the change in blood pressure during the VESAP and the change in stroke
volume after an infusion of 500 cc of crystalloid solution. Secondary endpoints will 1)
compare the predictive values of the VESAP and ΔPP; 2) look for pertinent VESAP threshold in
correlation with the expected increase in stroke volume; and 3) collection of the possible
complications due to the VESAP.
30 patients will be enrolled in this monocentric, open label, non-randomized study.
