Hemodynamic Optimization Through Pleth Variability Index for OHCA

NCT03841708 | Completed FDA Device

• 1 other identifier: HemOpt-PVI
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest With Successful Resuscitation

Keywords

Cardiac arrest; Hemodynamic monitoring; Non invasive monitoring; Pleth Variability Index; Adult cardiac arrest

Outcome Measures

Primary Outcomes (1)

• Change of lactate

  Change of lactate at 3h from admission. Lactate clearance will be measured as {(Admission lactate \[mmol/L\] - Lactate at time point \[mmol/L\]) / (Admission lactate \[mmol/L\])} x 100

  From ED admission until 6 hours from admission with 1 predefined time point at 3 hours from ED admission

Secondary Outcomes (8)

• Mortality 24h

  24 hours

• Mortality 72h

  72 hours

• Change of lactate

  From ED admission until 24 hours from admission with 3 predefined time points at 6,12 and 24 hours from ED admission

• Fluid balance first 48 hours

  48 hours

• Fluid balance first 24 hours

  24 hours

Study Arms (2)

Pleth Variability Index

ACTIVE COMPARATOR

In the experimental group patients will be hemodynamically resuscitated in the early phases after ROSC based on the pleth variability index on top of standard non invasive monitoring

Device: Pleth variability index

Standard non invasive monitoring

PLACEBO COMPARATOR

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.

Device: Standard non invasive monitoring

Interventions

Pleth variability index DEVICE

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%.

Also known as: Pleth Variability Index and standard non invasive monitoring

Pleth Variability Index

Standard non invasive monitoring DEVICE

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%.

Standard non invasive monitoring

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minor
• Prisoners
• Pregnant woman
• Atrial fibrillation

Sponsors & Collaborators

• Stefano Malinverni, MD: lead
• Andre Vesale Association: collaborator

Study Sites (1)

CHU Saint Pierre

Brussels, 1000, Belgium

Location

Related Publications (11)

• Nolan JP, Soar J, Cariou A, Cronberg T, Moulaert VR, Deakin CD, Bottiger BW, Friberg H, Sunde K, Sandroni C. European Resuscitation Council and European Society of Intensive Care Medicine Guidelines for Post-resuscitation Care 2015: Section 5 of the European Resuscitation Council Guidelines for Resuscitation 2015. Resuscitation. 2015 Oct;95:202-22. doi: 10.1016/j.resuscitation.2015.07.018. No abstract available.

  PMID: 26477702 BACKGROUND

• Gaieski DF, Band RA, Abella BS, Neumar RW, Fuchs BD, Kolansky DM, Merchant RM, Carr BG, Becker LB, Maguire C, Klair A, Hylton J, Goyal M. Early goal-directed hemodynamic optimization combined with therapeutic hypothermia in comatose survivors of out-of-hospital cardiac arrest. Resuscitation. 2009 Apr;80(4):418-24. doi: 10.1016/j.resuscitation.2008.12.015. Epub 2009 Feb 12.

  PMID: 19217200 BACKGROUND

• Cannesson M, Delannoy B, Morand A, Rosamel P, Attof Y, Bastien O, Lehot JJ. Does the Pleth variability index indicate the respiratory-induced variation in the plethysmogram and arterial pressure waveforms? Anesth Analg. 2008 Apr;106(4):1189-94, table of contents. doi: 10.1213/ane.0b013e318167ab1f.

  PMID: 18349191 BACKGROUND

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

• Aya HD, Cecconi M, Hamilton M, Rhodes A. Goal-directed therapy in cardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):510-7. doi: 10.1093/bja/aet020. Epub 2013 Feb 27.

  PMID: 23447502 BACKGROUND

• Benes J, Giglio M, Brienza N, Michard F. The effects of goal-directed fluid therapy based on dynamic parameters on post-surgical outcome: a meta-analysis of randomized controlled trials. Crit Care. 2014 Oct 28;18(5):584. doi: 10.1186/s13054-014-0584-z.

  PMID: 25348900 BACKGROUND

• Yin JY, Ho KM. Use of plethysmographic variability index derived from the Massimo((R)) pulse oximeter to predict fluid or preload responsiveness: a systematic review and meta-analysis. Anaesthesia. 2012 Jul;67(7):777-83. doi: 10.1111/j.1365-2044.2012.07117.x. Epub 2012 Mar 27.

  PMID: 22452345 BACKGROUND

• Topjian AA, Berg RA, Taccone FS. Haemodynamic and ventilator management in patients following cardiac arrest. Curr Opin Crit Care. 2015 Jun;21(3):195-201. doi: 10.1097/MCC.0000000000000205.

  PMID: 25887300 RESULT

• Loupec T, Nanadoumgar H, Frasca D, Petitpas F, Laksiri L, Baudouin D, Debaene B, Dahyot-Fizelier C, Mimoz O. Pleth variability index predicts fluid responsiveness in critically ill patients. Crit Care Med. 2011 Feb;39(2):294-9. doi: 10.1097/CCM.0b013e3181ffde1c.

  PMID: 21057311 RESULT

• Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1.

  PMID: 20035228 RESULT

• Malinverni S, Dumay P, Domont P, Claus M, Herpain A, Grignard J, Matta S, Bouazza FZ, Ochogavia Q. Postresuscitation pleth variability index-guided hemodynamic management of out-of-hospital cardiac arrest survivors: A randomised controlled trial. Resusc Plus. 2025 Mar 19;23:100933. doi: 10.1016/j.resplu.2025.100933. eCollection 2025 May.

  PMID: 40230365 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Stefano Malinverni, MD

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Academic Doctor

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available at study pubblication
• Access Criteria: Open access

Locations

BE (1)