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Neuroprotective Goal Directed Hemodynamic Optimization in Post-cardiac Arrest Patients (NEUROPROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02541591
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The primary objective of the Neuroprotect trial is to assess whether or not a new goal directed hemodynamic optimization strategy can reduce cerebral ischemia in post-cardiac arrest (CA) patients.

Condition or disease Intervention/treatment Phase
Cerebral Ischemia Cardiac Arrest Other: Neuroprotective goal directed hemodynamic optimization Other: MAP > 65mmHg Not Applicable

Detailed Description:
Unconscious patients admitted to the intensive care unit after being successfully resuscitated from cardiac arrest (CA) are at high risk for death, and neurological deficits are common among survivors. Nevertheless, the optimal hemodynamic strategy to ensure optimal cerebral perfusion and maximal outcome has not been studied by a randomized controlled trial. In the absence of good evidence, current post-CA guidelines are adapted from sepsis guidelines and recommend targeting a mean arterial pressure (MAP) above 65 mmHg (Peberdy ea, Circulation 2010). Importantly, post-CA patients have a large cerebral penumbra at risk for infarction when resuscitated to suboptimal MAP's. In a large subset of post-CA patients the lower threshold of cerebral autoregulation is shifted rightward and these patients might benefit from resuscitation to higher MAP's (Sundgreen ea, Stroke 2001) in order to ensure adequate cerebral oxygenation. Our research group previously showed that a MAP of 85-100mmHg results in optimal cerebral perfusion in post-CA patients (Ameloot ea, resuscitation 2015). Two retrospective and 2 prospective observational studies suggested an association between higher MAP's and better outcome in post-CA patients (Ameloot ea, resuscitation 2015). However, the value of these trials is limited by their observational design. The question remains as to whether patients with higher MAP's do have a better outcome due to more optimal cerebral perfusion and less cerebral damage or whether a higher MAP is merely a non-causal marker of more limited disease severity in these patients. In other words, the primary research question is whether we can reduce cerebral ischemia and improve prognosis of post-cardiac arrest survivors by targeting higher mean systemic blood pressures thereby optimizing cerebral perfusion during their stay in the intensive care unit. To answer this, we propose a multicenter interventional open label investigator driven randomized controlled trial to compare a goal-directed potentially neuro-protective hemodynamic optimization strategy with the current standard of care. Primary efficacy endpoints of the study will include extent of cerebral damage as assessed with diffusion weighted magnetic resonance imaging (DW-MRI), functional and neurocognitive testing, biomarkers of brain injury and survival rates. The final utilization goal of the Neuroprotect post-CA trial is to show that our adapted hemodynamic protocol reduces cerebral ischemia, and improves survival and functional outcome of post-cardiac arrest patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuroprotective Goal Directed Hemodynamic Optimization in Post-cardiac Arrest Patients: a Randomized Controlled Trial (the NEUROPROTECT Post-CA Trial)
Study Start Date : August 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: Neuroprotect
MAP between 85-100mmHg SVO2 between 65-75%
Other: Neuroprotective goal directed hemodynamic optimization
Active Comparator: Control
MAP>65mmHg
Other: MAP > 65mmHg
MAP > 65mmHg




Primary Outcome Measures :
  1. Diffusion weighted MRI [ Time Frame: day 4-5 ]
    cerebral ischemia in post-cardiac arrest (CA) patients as quantified by the apparent diffusion coefficient (ADC) on diffusion weighted MRI (DW-MRI) to be performed at day 4- 5 post-CA using ADC scores in 11 pre-specified brain regions (frontal cortex, parietal cortex, temporal cortex, occipital cortex, precentral cortex, postcentral cortex, caudate nucleus, putamen, thalamus, cerebellum, pons).


Secondary Outcome Measures :
  1. diffusion weighted MRI [ Time Frame: day 4-5 ]
    o Percentage of voxels under a suggested ADC threshold of 0.650x10-3 mm2/s

  2. Diffusion weighted MRI [ Time Frame: day 4-5 ]
    o Whole brain median ADC score [mm2/s]

  3. CPC [ Time Frame: 180 days after admission ]
    o Cerebral performance category 3-5 at 180 days post-CA

  4. The Short Form (36) Health Survey [ Time Frame: 180 days after admission ]
    o SF36 questionnaire at 180 days post-CA

  5. Neurocognitive testing [ Time Frame: discharge from the hospital (expected time frame 2-4 weeks after admission) ]
    Neurocognitive testing at discharge from the hospital by the adult verbal learning test

  6. Neurocognitive testing [ Time Frame: discharge from the hospital (expected time frame 2-4 weeks after admission) ]
    Neurocognitive testing at discharge from the hospital by the digit span backwards test

  7. Neurocognitive testing [ Time Frame: discharge from the hospital (expected time frame 2-4 weeks after admission) ]
    Neurocognitive testing at discharge from the hospital by the red pencil test

  8. Neurocognitive testing [ Time Frame: discharge from the hospital (expected time frame 2-4 weeks after admission) ]
    Neurocognitive testing at discharge from the hospital by the Wechsler Memory Scale Revised test

  9. Biomarkers [ Time Frame: day 1-2-3-4-5 ]
    Neuron specific enolase (day 1-2-3-4-5)

  10. Functional testing [ Time Frame: Discharge from the hospital (expected time frame 2-4 weeks after admission) ]
    Activities Daily Life (ADL)

  11. Functional testing [ Time Frame: Discharge from the hospital (expected time frame 2-4 weeks after admission) ]
    6 minute walking distance (6MWD) at discharge from the hospital

  12. ICU parameters [ Time Frame: At ICU discharge (expected time frame 1-2 weeks after admission) ]
    lenght of stay in ICU [number of days]

  13. ICU parameters [ Time Frame: At ICU discharge (expected time frame 1-2 weeks after admission) ]
    Ventilator days [number of days]

  14. ICU parameters [ Time Frame: At ICU discharge (expected time frame 1-2 weeks after admission) ]
    tracheostomy performed (yes/no)

  15. Renal function [ Time Frame: day 1-2-3-4-5 ]
    creatinine [mg/dl]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Out-of-hospital CA of presumed cardiac cause irrespective of the presenting rhythm
  2. Unconsciousness (Glasgow coma scale < 8) at hospital admission
  3. Age ≥ 18 years
  4. Sustained return of spontaneous circulation (ROSC) (=when chest compressions have not been required for 20 consecutive minutes)

Exclusion Criteria:

  1. Suspected or confirmed intracranial bleeding or stroke
  2. Known limitations in therapy or Do Not Resuscitate-order
  3. Known disease compromising 180 day survival
  4. Known pre-CA cerebral performance category 3-4
  5. Previous stroke (TIA can be included)
  6. MRI incompatible cardiac or neurosurgical device
  7. Systolic blood pressure < 90 mmHg on norepinephrine > 1 mcg/kg/min).
  8. Open chest
  9. ECMO (extracorporeal membrane oxygenation)
  10. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541591


Locations
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Belgium
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Ziekenhuis Oost-Limburg
Investigators
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Principal Investigator: Koen Ameloot, MD UZ Leuven
Principal Investigator: Stefan Janssens, MD UZ Leuven
Principal Investigator: Joseph Dens, MD Ziekenhuis Oost-Limburg
Principal Investigator: Cathy De Deyne, MD Ziekenhuis Oost-Limburg

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02541591    
Other Study ID Numbers: s58017
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by Universitaire Ziekenhuizen Leuven:
post cardiac arrest
hemodynamics
Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Heart Arrest
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Stroke