Clinical trial NCT03841708: Hemodynamic Optimization Through Pleth Variability Index for OHCA
Official title: Impact on Lactate Clearance of Early Hemodynamic Optimization Through Pleth Variability Index in the ED for Resuscitated Out-of-hospital Cardiac Arrests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest With Successful Resuscitation
Keywords: Cardiac arrest
Hemodynamic monitoring
Non invasive monitoring
Pleth Variability Index
Adult cardiac arrest
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Andre Vesale Association
First posted: 2019-02-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this monocentric placebo controlled single blind ranomized clinical trial patients will be recruited from the Emergency Department of a University Hospital.

80 patients suffering form a out of hospital cardiac attest arriving at the Emergency Department with a lactate level \> 4 mmol/L or a mean arterial pressure below 65 mmHg will be included in the study at the moment of admission to the Emergency Department and patients in the treatment arm will be monitored on top of standard monitoring with a non invasive device measuring continuously the pleth variability index(PVI). Patients in the treatment arm will be treated according to an algorithm integrating both standard non invasive measures and the PVI. Patients in the control arm will be treated according to non invasive measures only.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Less than half of the patients suffering from sudden cardiac arrest arrive at the hospital alive. Of 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 from out of hospital cardiac arrest patients are hemodynamically unstable and management relies on few non invasive measurements such as non invasive blood pressure, SatO2, EtCO2 and continuous ECG.

Even at arrival at the ER patients are monitored by non-invasive parameters during the early phases and invasive hemodynamic monitoring may be delayed until ICU admission. Recent technological advances allow continuous non invasive evaluation of response to fluid challenge in mechanically ventilated patients through the pleth variability index.

The research proposal by the investigator is a randomized prospective interventional, single-center study based at Saint Pierre University Hospital, carried out in the emergency department.

Participant will be OHCA admitted alive to the Emergency department with unstable hemodynamics defined as a mean systolic pressure below 70 mmHg or a blood lactate concentration of at least 36 mg/dL (4 mmol/L).

The criteria for exclusion from the study will be pregnancy, being a prisoner or having limitations of therapeutic effort.

During the study the investigators will evaluate whether an hemodynamic protocol based on pleth variability index on top of routine non invasive monitoring is superior to the routine non invasive monitoring only ( such as non invasive blood pressure, EtCO2, SatO2 and ECG) in terms of lactate clearance and fluid balance.

In both study arms the treating clinician will be encouraged to achieve and maintain the following hemodynamics goals: a mean arterial pressure above 70mmHg, a diuresis above 0.5 ml/kg/h, a capillary refill time below 3 and a clearance of lactate above 10% after 2 hours.

In the control arm the participants will be initially resuscitated with an initial bolus of NaCl 0.9% 10ml/kg whenever the patient is not meeting the set hemodynamic goals. If deemed necessary a second fluid challenge of 100 ml of Albumin 20% will be administered to the patient. Any further fluid challenge will be done with NaCl 0.9% 10ml/kg. At any moment the treating clinician will be allowed to initiate a continuous infusion of noradrenaline or dobutamine to achieve the hemodynamic goals. If deemed necessary clinicians will be allowed to perform a cardiac echography at any moment to assess the hemodynamic needs of the patient. Patients will be continuously reassessed to verify that the hemodynamic goals are achieved.

In the intervention arm patient will be resuscitated according to their PVI. Whenever the PVI will be above 13% the patient will be considered as being fluid responsive and a fluid challenge will be performed whenever the patient is not meeting the set hemodynamic goals. First fluid challenge will be an initial bolus of NaCl 0.9% 10ml/kg. If deemed necessary a second fluid challenge of 100 ml of Albumin 20% will be administered to the patient. Any further fluid challenge will be done with NaCl 0.9% 10ml/kg. If the hemodynamic goals are not achieved and the PVI is below 13% an infusion of noradrenaline will be initiated aiming at a mean arterial pressure of at least 70 mmHg. Infusion of dobutamine to achieve the hemodynamic goals will be started according to clinician decision. If deemed necessary clinicians will be allowed to perform a cardiac echography at any moment to assess the hemodynamic needs of the patient.

Patients will be continuously reassessed to verify that the hemodynamic goals are achieved.

In both arms participants will be sedated according to our hospital protocol for OHCA which includes propofol and remifentanyl titrated to achieve a good synchronization between the patient and the ventilator. If despite sedation a good synchronization between the patient and the ventilator cannot be achieved participants will be initially curarized.

Intervention will end at ICU admission when hemodynamic therapeutic decisions will be based on invasive hemodynamic monitoring.

Trainings will be organized for nurses and postgraduate doctors during the months preceding the study to familiarize the medical-nursing team with the study.

Eligibility criteria: Inclusion Criteria:

* Out of Hospital Cardiac Arrest
* ROSC before Emergency department admission
* Mecanically ventilated with a tidal volume of at least 6 ml/IBW
* Admitted to the emergency department with a lactate \> 4mmol/L or a mean arterial pressure below 65 mmHg or a TRC\>5 seconds

Exclusion Criteria:

* Minor
* Prisoners
* Pregnant woman
* Atrial fibrillation

Primary outcomes:
measure: Change of lactate
timeFrame: From ED admission until 6 hours from admission with 1 predefined time point at 3 hours from ED admission
Secondary outcomes:
measure: Mortality 24h
timeFrame: 24 hours
measure: Mortality 72h
timeFrame: 72 hours
measure: Change of lactate
timeFrame: From ED admission until 24 hours from admission with 3 predefined time points at 6,12 and 24 hours from ED admission
measure: Fluid balance first 48 hours
timeFrame: 48 hours
measure: Fluid balance first 24 hours
timeFrame: 24 hours
measure: SOFA 24 hours
timeFrame: 24 hours
measure: CPC at hospital discharge
timeFrame: At 16 weeks or at hospital discharge whichever comes first
measure: Normalization of lactate
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint Pierre
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Stefano Malinverni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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