NCT02607878

Brief Summary

Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA). Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly improve prognostication of post-CA coma, however, EEG and SSEP are not always available and require specific expertise for their interpretation. Automated video pupillometry is a novel electronic device that contains an infrared light camera which enables to measure quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a recent study of a cohort of comatose CA survivors (n=50 patients) it was found that quantitative PLR was more accurate than standard PLR (manual pen light) in predicting 3-month outcome, irrespective of temperature and sedation, and had comparable prognostic accuracy than electrophysiological exams, including electroencephalography (EEG) and somato-sensory evoked potentials (SSEP). Aim of the study: In light of these promising results, the investigators would like to confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose post-CA patients. Design of the study: Prospective, multicenter, observational outcome trial.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
8 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

November 2, 2015

Last Update Submit

September 8, 2021

Conditions

Cardiac ArrestComatose

Keywords

Cardiac arrestComaPrognosisAutomated pupillometryEEGEvoked potentialsTargeted Temperature Management (TTM)

Outcome Measures

Primary Outcomes (1)

  • Neurological outcome

    Neurological outcome is assessed by a semi-structured telephone interview with the patient or the patient's relatives using the Glasgow-Pittsburgh Cerebral Performance Categories (CPC). The CPC result is then categorized as favorable outcome (CPC 1-2, including good recovery and moderate disability), vs. unfavorable outcome (CPC 3-5, including severe disability, vegetative state and death).

    3-6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with coma after cardiac arrest (CA)

You may qualify if:

  • Adult patients with coma after cardiac arrest (CA)
  • Patients with CA due to ventricular fibrillation (VF) and non-VF (including asystole and pulseless electrical activity) rhythms
  • Cardiac and non-cardiac causes of CA will be included

You may not qualify if:

  • Age \< 18 years
  • Unable to obtain consent
  • Follow-up unavailable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Erasme University Hospital

Brussels, Belgium

Location

University Hospital, Grenoble

Grenoble, France

Location

Cochin Hospital

Paris, France

Location

Charite University, Berlin, Germany

Berlin, Germany

Location

Azienda Ospedaliera San Gerardo di Monza

Monza, Italy

Location

Catholic University of the Sacred Heart

Roma, Italy

Location

Centre Hospitalier du Luxembourg

Luxembourg, Luxembourg

Location

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, Netherlands

Location

Lund University Hospital

Lund, Sweden

Location

CHUV, Lausanne University Hospital

Lausanne, Switzerland

Location

MeSH Terms

Conditions

Heart ArrestComa

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mauro Oddo, MD

    CHUV, Lausanne University Hospital, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médecin adjoint, PD-MER I

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 18, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)DE(1)SE(1)IT(2)CH(1)NL(1)LU(1)BE(1)