Trial Outcomes & Findings for Neuroprotective Goal Directed Hemodynamic Optimization in Post-cardiac Arrest Patients (NCT NCT02541591)

Last Updated: 2024-04-12

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

112 participants

Primary outcome timeframe

day 4-5

Results posted on

2024-04-12

Participant Flow

Emergency care

Participant milestones

Participant milestones
Measure	Neuroprotect MAP between 85-100mmHg SVO2 between 65-75% Neuroprotective goal directed hemodynamic optimization	Control MAP\>65mmHg MAP \> 65mmHg: MAP \> 65mmHg
Overall Study STARTED	56	56
Overall Study COMPLETED	52	55
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuroprotect n=52 Participants MAP between 85-100mmHg SVO2 between 65-75% Neuroprotective goal directed hemodynamic optimization	Control n=55 Participants MAP\>65mmHg MAP \> 65mmHg: MAP \> 65mmHg	Total n=107 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=52 Participants	0 Participants n=55 Participants	0 Participants n=107 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=52 Participants	27 Participants n=55 Participants	53 Participants n=107 Participants
Age, Categorical >=65 years	26 Participants n=52 Participants	28 Participants n=55 Participants	54 Participants n=107 Participants
Age, Continuous	64 years STANDARD_DEVIATION 12 • n=52 Participants	65 years STANDARD_DEVIATION 13 • n=55 Participants	65 years STANDARD_DEVIATION 12 • n=107 Participants
Sex: Female, Male Female	13 Participants n=52 Participants	13 Participants n=55 Participants	26 Participants n=107 Participants
Sex: Female, Male Male	39 Participants n=52 Participants	42 Participants n=55 Participants	81 Participants n=107 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Belgium	52 participants n=52 Participants	55 participants n=55 Participants	107 participants n=107 Participants

PRIMARY outcome

Timeframe: day 4-5

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Neuroprotect n=52 Participants MAP between 85-100mmHg SVO2 between 65-75% Neuroprotective goal directed hemodynamic optimization	Control n=55 Participants MAP\>65mmHg MAP \> 65mmHg: MAP \> 65mmHg
% of Ischaemic Voxels With an ADC<0.65 mm2/s on Day 4-5 (Diffusion Weighted MRI)	10.6 percentage of ischaemic voxels Interval 8.0 to 18.4	11.0 percentage of ischaemic voxels Interval 8.4 to 14.8

Adverse Events

Neuroprotect

Serious events: 7 serious events

Other events: 0 other events

Deaths: 31 deaths

Control

Serious events: 21 serious events

Other events: 0 other events

Deaths: 29 deaths

Serious adverse events

Serious adverse events
Measure	Neuroprotect n=52 participants at risk MAP between 85-100mmHg SVO2 between 65-75% Neuroprotective goal directed hemodynamic optimization	Control n=55 participants at risk MAP\>65mmHg MAP \> 65mmHg: MAP \> 65mmHg
Cardiac disorders arrhythmia	13.5% 7/52 • Number of events 7 • During intervention period (36 hours)	23.6% 13/55 • Number of events 13 • During intervention period (36 hours)
Cardiac disorders Limb ischaemia	0.00% 0/52 • During intervention period (36 hours)	1.8% 1/55 • Number of events 1 • During intervention period (36 hours)
Cardiac disorders Atrial fibrillation	0.00% 0/52 • During intervention period (36 hours)	7.3% 4/55 • Number of events 4 • During intervention period (36 hours)
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/52 • During intervention period (36 hours)	3.6% 2/55 • Number of events 2 • During intervention period (36 hours)
Cardiac disorders death	0.00% 0/52 • During intervention period (36 hours)	1.8% 1/55 • Number of events 1 • During intervention period (36 hours)
Cardiac disorders EMD	1.9% 1/52 • Number of events 1 • During intervention period (36 hours)	0.00% 0/55 • During intervention period (36 hours)
Vascular disorders serious hypotension	0.00% 0/52 • During intervention period (36 hours)	1.8% 1/55 • Number of events 1 • During intervention period (36 hours)
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/52 • During intervention period (36 hours)	1.8% 1/55 • Number of events 1 • During intervention period (36 hours)
Cardiac disorders cardiogenic shock	0.00% 0/52 • During intervention period (36 hours)	1.8% 1/55 • Number of events 1 • During intervention period (36 hours)

Other adverse events

Adverse event data not reported

Additional Information

Koen Ameloot

ZOL Genk

Phone: 0485685969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place