Neuroprotective Goal Directed Hemodynamic Optimization in Post-cardiac Arrest Patients

NCT02541591 | Completed Results DMC

• 1 other identifier: s58017
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Ischemia; Cardiac Arrest

Keywords

post cardiac arrest; hemodynamics

Outcome Measures

Primary Outcomes (1)

• % of Ischaemic Voxels With an ADC<0.65 mm2/s on Day 4-5 (Diffusion Weighted MRI)

  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).

  day 4-5

Study Arms (2)

Neuroprotect

EXPERIMENTAL

MAP between 85-100mmHg SVO2 between 65-75%

Other: Neuroprotective goal directed hemodynamic optimization

Control

ACTIVE COMPARATOR

MAP\>65mmHg

Other: MAP > 65mmHg

Interventions

Neuroprotective goal directed hemodynamic optimization OTHER

Neuroprotect

MAP > 65mmHg OTHER

MAP \> 65mmHg

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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 \< 90 mmHg on norepinephrine \> 1 mcg/kg/min).
• Open chest
• ECMO (extracorporeal membrane oxygenation)
• Pregnancy

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (2)

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (3)

• Laurikkala J, Ameloot K, Reinikainen M, Palmers PJ, De Deyne C, Bert F, Dupont M, Janssens S, Dens J, Hastbacka J, Jakkula P, Loisa P, Birkelund T, Wilkman E, Vaara ST, Skrifvars MB. The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials. Ann Intensive Care. 2023 Nov 21;13(1):113. doi: 10.1186/s13613-023-01210-0.

  PMID: 37987871 DERIVED

• Wouters A, Scheldeman L, Plessers S, Peeters R, Cappelle S, Demaerel P, Van Paesschen W, Ferdinande B, Dupont M, Dens J, Janssens S, Ameloot K, Lemmens R. Added Value of Quantitative Apparent Diffusion Coefficient Values for Neuroprognostication After Cardiac Arrest. Neurology. 2021 May 25;96(21):e2611-e2618. doi: 10.1212/WNL.0000000000011991. Epub 2021 Apr 9.

  PMID: 33837117 DERIVED

• Ameloot K, Jakkula P, Hastbacka J, Reinikainen M, Pettila V, Loisa P, Tiainen M, Bendel S, Birkelund T, Belmans A, Palmers PJ, Bogaerts E, Lemmens R, De Deyne C, Ferdinande B, Dupont M, Janssens S, Dens J, Skrifvars MB. Optimum Blood Pressure in Patients With Shock After Acute Myocardial Infarction and Cardiac Arrest. J Am Coll Cardiol. 2020 Aug 18;76(7):812-824. doi: 10.1016/j.jacc.2020.06.043.

  PMID: 32792079 DERIVED

MeSH Terms

Conditions

Brain Ischemia; Heart Arrest

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Results Point of Contact

• Title: Koen Ameloot
• Organization: ZOL Genk

koen.ameloot@zol.be

0485685969

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 4, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2018-06

Locations

BE (2)