Cardiac Arrest With Successful ResuscitationHemOpt-PVINCT03841708
Hemodynamic Optimization Through Pleth Variability Index for OHCA
A study testing Pleth variability index and Standard non invasive monitoring in people with Cardiac Arrest With Successful Resuscitation, run by Stefano Malinverni, MD at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiac Arrest With Successful Resuscitation
- What is being tested?
- Pleth variability index and Standard non invasive monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minor
- Prisoners
- Pregnant woman
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on Lactate Clearance of Early Hemodynamic Optimization Through Pleth Variability Index in the ED for Resuscitated Out-of-hospital Cardiac Arrests
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.
Read more
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.
Read the 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.
- Being tested
- Pleth variability index, Standard non invasive monitoring
- Keywords
- Cardiac arrest, Hemodynamic monitoring, Non invasive monitoring, Pleth Variability Index, Adult cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleth variability indexDevice
Also called Pleth Variability Index and standard non invasive monitoring
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%.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Standard non invasive monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From ED admission until 6 hours from admission with 1 predefined time point at 3 hours from ED admission
Secondary outcomes (8)
Mortality 24h
Mortality at 24 hours: measured as the rate of mortality during the first 24 hours from ER admission within the two study groups
Measured: 24 hours
Mortality 72h
Mortality at 72 hour:s measured as the rate of mortality during the first 72hours from ER admission within the two study groups
Measured: 72 hours
Change of lactate
Change of lactate at 6h 12h and 24h from admission. Lactate clearance will be measured as {(Admission lactate [mmol/L] - Lactate at time point [mmol/L]) / (Admission lactate [mmol/L])} x 100. Patients dying during the observation period will be imputated a lactate clearance of 0
Measured: 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
Fluid balance at 48 hours post ROSC. Fluid balance will be measured from treatment chart as follows: [total fluid intake from ER admission to 48 hours post ER admission (crystalloids, colloids, drugs dilution fluids) - total urine output from ER admission until 48th hours since ER admission]
Measured: 48 hours
Fluid balance first 24 hours
Fluid balance at 24 hours post ROSC. Fluid balance will be measured from treatment chart as follows: [total fluid intake from ER admission to 24 hours post ER admission (crystalloids, colloids, drugs dilution fluids) - total urine output from ER admission until 24th hours since ER admission]
Measured: 24 hours
SOFA 24 hours
SOFA at 24 hours post-ROSC: The Sequential Organ Failure Assessment score (SOFA) regroups six different scores one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. It ranges from 0 to 24. Higher values of the score are associated with worse outcome. It will be calculated based on laboratory and clinical values collected closest to the 24th hour since ER admission within the time window going from 18 hours to 30 hours. Since the investigators expect all patients included in this study to be intubated and sedated, GCS would be of limited value and therefore the final CPC score minus 1 will be used as the neurologic failure component.
Measured: 24 hours
CPC at hospital discharge
CPC at hospital discharge: Cerebral Performance Category (CPC) ranges from 1 to 5. It will be recovered from hospital records describing the clinical condition at the precise moment of patient discharge. Good clinical outcome will be defined as Cerebral performance category 1 or 2 at hospital discharge.
Measured: At 16 weeks or at hospital discharge whichever comes first
Normalization of lactate
Time measured in hours it takes from admission to reach a lactate level < 2mmol/L
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest With Successful ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefano Malinverni, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Andre Vesale Association
- Responsible party
- Sponsor-investigator, Stefano Malinverni, MD, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Stefano Malinverni, MD, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841708
- Sponsor's protocol ID
- HemOpt-PVI
- Acronym
- HemOpt-PVI
- Status last verified
- Nov 2024
- First submitted
- 30 Jan 2019
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The full database of the study will be accessible from the public after termination and publication of the study
Publications
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.
PubMed 26477702Gaieski 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.
PubMed 19217200Cannesson 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.
PubMed 18349191Rivers 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.
PubMed 11794169Aya 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.
PubMed 23447502Benes 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.
PubMed 25348900Yin 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.
PubMed 22452345Topjian 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.
PubMed 25887300Loupec 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.
PubMed 21057311Zimmermann 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.
PubMed 20035228Malinverni 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.
PubMed 40230365
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Lactate Clearance of Early Hemodynamic Optimization Through Pleth Variability Index in the ED for Resuscitated Out-of-hospital Cardiac Arrests
- ClinicalTrials.gov ID
- NCT03841708
- Acronym / sponsor ID
- HemOpt-PVI / HemOpt-PVI
- Keywords
- Cardiac arrest, Hemodynamic monitoring, Non invasive monitoring, Pleth Variability Index, Adult cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Stefano Malinverni, MDUniversity, hospital or other
- Collaborators
- Andre Vesale Association
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pleth Variability Index | Active comparator | Device: Pleth variability indexIn 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 |
| Standard non invasive monitoring | Placebo comparator | Device: Standard non invasive monitoringIn 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Minor
- Prisoners
- Pregnant woman
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleth variability indexAlso: Pleth Variability Index and standard non invasive monitoringThe 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%. | Device | Pleth Variability Index |
| Standard non invasive monitoringIn 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%. | Device | Standard non invasive monitoring |
Primary outcome
Change of lactate
Time frame: From ED admission until 6 hours from admission with 1 predefined time point at 3 hours from ED admission
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
8 secondary outcomes
Mortality 24h
Time frame: 24 hours
Mortality 72h
Time frame: 72 hours
Change of lactate
Time frame: 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
Time frame: 48 hours
Fluid balance first 24 hours
Time frame: 24 hours
SOFA 24 hours
Time frame: 24 hours
CPC at hospital discharge
Time frame: At 16 weeks or at hospital discharge whichever comes first
Normalization of lactate
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 26477702Nolan 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.
- Background: PubMed 19217200Gaieski 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.
- Background: PubMed 18349191Cannesson 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.
- Background: PubMed 11794169Rivers 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.
- Background: PubMed 23447502Aya 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.
- Background: PubMed 25348900Benes 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.
- Background: PubMed 22452345Yin 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.
- Results publication: PubMed 25887300Topjian 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.
- Results publication: PubMed 21057311Loupec 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.
- Results publication: PubMed 20035228Zimmermann 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.
- Derived from this study: PubMed 40230365Malinverni 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.
- Individual participant dataSharing planned: Yes. The full database of the study will be accessible from the public after termination and publication of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Malinverni, MD principal investigator
Centre Hospitalier Universitaire Saint Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleth variability index and Standard non invasive monitoring in people with Cardiac Arrest With Successful Resuscitation, run by Stefano Malinverni, MD at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lactate (time frame: From ED admission until 6 hours from admission with 1 predefined time point at 3 hours from ED admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03841708, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.