CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
Pleth variability index +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03841708
NCT03841708N/ACompleted

Impact on Lactate Clearance of Early Hemodynamic Optimization Through Pleth Variability Index in the ED for Resuscitated Out-of-hospital Cardiac Arrests

Stefano Malinverni, MD·interventional·Posted Feb 15, 2019·Updated Nov 20, 2024

In Brief

A clinical study evaluating Pleth variability index and Standard non invasive monitoring for Cardiac Arrest With Successful Resuscitation. Completed, enrolled 82 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 15, 2019
Enrollment StartMar 1, 2019
Primary CompletionSep 1, 2023
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.4 years ago

Interventions

Pleth variability indexdevice

The utility of a early goal directed therapy will be evaluate by the pleth variability index (PVI). If above\>13% in a well sedated patients perfectly synchronized with the ventilator providing at least 6ml/kg of ideal body weight, a fluid challeng with 10ml/kg of NaCl 0,9% will be administrated. Patient will be constantly re-assessed until the hemodynamic goals of a mean arterial pressure above 65 mmHg, a capillary refill time below 3 seconds, a decreasing trend on lactates and a urinary output above 0.5/ml/kg/h will be achieved. The second fluid challenge will always be performed with 100 ml of albumin 20%. The third fluid challenge if necessary will be performed with 10 ml/kg of NaCl 0.9%.

Standard non invasive monitoringdevice

In the control group patients will be hemodynamically resuscitated in the early phases after ROSC based on standard non invasive monitoring such as SatO2, EtCO2, non invasive blood pressure and continuous ECG. If deemed necessary by the treating physician a fluid challenge of 10ml/kg of NaCl 0,9% will be administrated. Patient will be constantly re-assessed until the hemodynamic goals of a mean arterial pressure above 65 mmHg, a capillary refill time below 3 seconds, a decreasing trend on lactates and a urinary output above 0.5/ml/kg/h will be achieved. The second fluid challenge will always be performed with 100 ml of albumin 20%. The third fluid challenge if necessary will be performed with 10 ml/kg of NaCl 0.9%.