Neuroprotective goal directed hemodynamic optimization in post-cardiac arrest patients: a randomized controlled trial (the NEUROPROTECT post-CA trial)

Neuroprotective goal directed hemodynamic optimization in post-cardiac arrest patients: a randomized controlled trial (the NEUROPROTECT post-CA trial) - NEUROPROTECT post-CA trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002151-10-BE

Enrollment

Unknown

Registered

2015-06-01

Start date

2015-08-07

Completion date

Unknown

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-cardiac arrest patients MedDRA version: 18.0 Level: HLT Classification code 10047283 Term: Ventricular arrhythmias and cardiac arrest System Organ Class: 100000004849

Interventions

Trade Name: Dobutamine EG 250 mg/20 ml concentraat voor oplossing voor infusie Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: DOBUTAMINE HYDROCHLORIDE CAS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Out-of-hospital CA of presumed cardiac cause irrespective of the presenting rhythm - Unconsciousness (Glasgow coma scale =65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: - Suspected or confirmed intracranial bleeding or stroke - Known limitations in therapy or Do Not Resuscitate-order - Known disease compromising 180 day survival - Known pre-CA cerebral performance category 3-4 - Previous stroke (TIA can be included) - MRI incompatible cardiac or neurosurgical device - Systolic blood pressure 1 mcg/kg/min). - Open chest - ECMO (extracorporeal membrane oxygenation) - Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to assess whether or not a new goal directed hemodynamic optimization strategy can reduce 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 Objective: Secondary efficacy outcomes: o Percentage of voxels under a suggested ADC threshold of 0.650.10-3 mm2/s o Whole brain median ADC score o Cerebral performance category 3-5 at discharge from the ICU o Cerebral performance category 3-5 at 180 days post-CA o SF36 questionnaire at 180 days post-CA o Neurocognitive testing at discharge from the hospital o Biomarkers: Neuron specific enolase (day 1-2-3-4-5) o Functional testing: Activities Daily Life (ADL) and 6 minute walking distance (6MWD) at discharge from the hospital o Renal function: creatinine day 1-2-3-4-5 and urinary output day 1-2-3-4-5. o Length of stay in the ICU o Duration of mechanical ventilation - Safety outcomes: ? Incidence of life threatening arrhythmias, new onset atrial fibrillation and pulmonary congestion requiring diuretics during intervention period ;Primary end point(s): Cerebral ischemia 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). The primary endpoint of interest will be defined as the average across the 11 regions.;Timepoint(s) of evaluation of this end point: at day 4- 5 post-CA	—

Measure

Time frame

Main Objective: The primary objective of the trial is to assess whether or not a new goal directed hemodynamic optimization strategy can reduce 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 Objective: Secondary efficacy outcomes: o Percentage of voxels under a suggested ADC threshold of 0.650.10-3 mm2/s o Whole brain median ADC score o Cerebral performance category 3-5 at discharge from the ICU o Cerebral performance category 3-5 at 180 days post-CA o SF36 questionnaire at 180 days post-CA o Neurocognitive testing at discharge from the hospital o Biomarkers: Neuron specific enolase (day 1-2-3-4-5) o Functional testing: Activities Daily Life (ADL) and 6 minute walking distance (6MWD) at discharge from the hospital o Renal function: creatinine day 1-2-3-4-5 and urinary output day 1-2-3-4-5. o Length of stay in the ICU o Duration of mechanical ventilation - Safety outcomes: ? Incidence of life threatening arrhythmias, new onset atrial fibrillation and pulmonary congestion requiring diuretics during intervention period ;Primary end point(s): Cerebral ischemia 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). The primary endpoint of interest will be defined as the average across the 11 regions.;Timepoint(s) of evaluation of this end point: at day 4- 5 post-CA

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Secondary

Measure	Time frame
Secondary end point(s): • Secondary efficacy outcomes: o Percentage of voxels under a suggested ADC threshold of 0.650.10-3 mm2/s o Whole brain median ADC score o Cerebral performance category 3-5 at discharge from the ICU CPC 1: return to normal cerebral function and normal living CPC 2: Disability but sufficient function for independent activities of daily life CPC 3: severe disability CPC 4: Coma CPC 5: Death o Cerebral performance category 3-5 at 180 days post-CA (assessed by trial investigators that are unaware of the treatment assignment) o SF36 questionnaire at 180 days post-CA (assessed by trial investigators that are unaware of the treatment assignment) o Neurocognitive testing at discharge from the hospital o Biomarkers: Neuron specific enolase (day 1-2-3-4-5) o Functional testing: Activities Daily Life (ADL) and 6 minute walking distance (6MWD) at discharge from the hospital o Renal function: creatinine day 1-2-3-4-5 and urinary output day 1-2- 3-4-5. o Length of stay in the ICU o Duration of mechanical ventilation • Safety outcomes: o Incidence of life threatening arrhythmias during intervention period o Incidence of new onset atrial fibrillation during intervention period o Incidence of pulmonary congestion requiring diuretics during intervention period ;Timepoint(s) of evaluation of this end point: • At day 4-5 o Brain MRI with diffusion weighted imaging • At ICU discharge: o Cerebral performance category score • At hospital discharge o Cognitive testing o ADL o 6 MWD o Cerebral performance category score • At 180 days post-CA o Cerebral performance category score o SF36	—

Measure

Time frame

Secondary end point(s): • Secondary efficacy outcomes: o Percentage of voxels under a suggested ADC threshold of 0.650.10-3 mm2/s o Whole brain median ADC score o Cerebral performance category 3-5 at discharge from the ICU CPC 1: return to normal cerebral function and normal living CPC 2: Disability but sufficient function for independent activities of daily life CPC 3: severe disability CPC 4: Coma CPC 5: Death o Cerebral performance category 3-5 at 180 days post-CA (assessed by trial investigators that are unaware of the treatment assignment) o SF36 questionnaire at 180 days post-CA (assessed by trial investigators that are unaware of the treatment assignment) o Neurocognitive testing at discharge from the hospital o Biomarkers: Neuron specific enolase (day 1-2-3-4-5) o Functional testing: Activities Daily Life (ADL) and 6 minute walking distance (6MWD) at discharge from the hospital o Renal function: creatinine day 1-2-3-4-5 and urinary output day 1-2- 3-4-5. o Length of stay in the ICU o Duration of mechanical ventilation • Safety outcomes: o Incidence of life threatening arrhythmias during intervention period o Incidence of new onset atrial fibrillation during intervention period o Incidence of pulmonary congestion requiring diuretics during intervention period ;Timepoint(s) of evaluation of this end point: • At day 4-5 o Brain MRI with diffusion weighted imaging • At ICU discharge: o Cerebral performance category score • At hospital discharge o Cognitive testing o ADL o 6 MWD o Cerebral performance category score • At 180 days post-CA o Cerebral performance category score o SF36

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Countries

Belgium

Contacts

Public ContactKoen Ameloot

UZ Leuven

koen.ameloot@uzleuven.be3216344235

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

Neuroprotective goal directed hemodynamic optimization in post-cardiac arrest patients: a randomized controlled trial (the NEUROPROTECT post-CA trial)

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Outcome results