NCT03841708: HemOpt-PVI

Hemodynamic Optimization Through Pleth Variability Index for OHCA

Completed NA Last updated 20 November 2024

What this trial tests

NA trial testing Pleth variability index in Cardiac Arrest With Successful Resuscitation in 82 participants. Completed in 30 September 2023.

Timeline

1 March 2019

Primary endpoint
1 September 2023

30 September 2023

Quick facts

Lead sponsor	Stefano Malinverni, MD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	82
Start date	1 March 2019
Primary completion	1 September 2023
Estimated completion	30 September 2023
Sites	1 location across Belgium

Drugs / interventions tested

• Pleth variability index
• Standard non invasive monitoring

Conditions studied

• Cardiac Arrest With Successful Resuscitation — all drugs for Cardiac Arrest With Successful Resuscitation →

Sponsor

Stefano Malinverni, MD

Who can join

Adults 18 to 99, any sex, with Cardiac Arrest With Successful Resuscitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Less than half of the patients suffering from sudden cardiac arrest arrive at the hospital alive. Within these survivors less than half will be discharged alive from the hospital without being severely disabled.

The most frequent cause of death during the first 24 hours since admission to the hospital is related to cardiovascular instability and failure. In the early phases of ROSC patients are hemodynamically unstable and management for out of hospital cardiac arrests relies on few non invasive measurements such as non invasive blood pressure, SatO2, EtCO2 and continuous ECG. Recent technological advances allow continuous non invasive evaluation of response to fluid challenge in mechanically ventilated patients through the pleth variability index.

The investigators hypothesize that early goal directed therapy based on non invasive measurement of the pleth variability index on top of conventional non-invasive monitor during the initial care in the Emergency Department can improve the hemodynamic status of the participants, increase lactate clearance and reduce fluid balance at 48 hours post arrest.

Objectives:

* To determine whether an early goal directed management based on the pleth variability index on top of standard non invasive hemodynamic monitoring could improve the hemodynamic status of patients post cardiac arrest especially in terms of increase in lactate clearance and reduced fluid balance. Neurological outcome will be investigated.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Postresuscitation pleth variability index-guided hemodynamic management of out-of-hospital cardiac arrest survivors: A randomised controlled trial.
   Malinverni S, Dumay P, Domont P, Claus M, et al · · 2025 · PMID 40230365 · DOI 10.1016/j.resplu.2025.100933