NCT02201134

Brief Summary

Studying the feasibility of an initial sedation with inhalated sevoflurane during therapeutic hypothermia of cardiac arrests resuscitated patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 14, 2025

Status Verified

May 1, 2021

Enrollment Period

3.4 years

First QC Date

July 16, 2014

Last Update Submit

July 9, 2025

Conditions

Cardiac ArrestTherapeutic Hypothermia

Keywords

Cardiac arrestTherapeutic hypothermiaSevofluraneSedationPatient resuscitated from cardiac arrestRequiring sedationAdult patientsPatient covered by french health care system

Outcome Measures

Primary Outcomes (1)

  • Determination of the feasibility of a sedation with inhalated sevoflurane in cardiac arrest resuscitated patients

    The feasibility is evaluated by the number of side effects due to treatment until discharge from hospital.

    at day 1

Secondary Outcomes (4)

  • Determination of neurological prognostic of patients at ICU and hospital discharge

    at day 1

  • Determination of systemic complications and organ failures during hospitalisation

    at day 1

  • Evaluation of systemic inflammation and evolution with cytokines

    at day 1

  • Evaluation of markers specific of brain ischemia (S100 protein and neuron-specific enolase)

    at day 1

Study Arms (1)

sevoflurane

OTHER
Drug: sevoflurane

Interventions

sevofluraneDRUG
sevoflurane

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients ventilated requiring therapeutic hypothermia in ICU
  • Stable respiratory and hemodynamic conditions
  • Epinephrine and norepinephrine infusion rate \< 1,5 g/kg/min
  • Consent of patients or family
  • Arterial line
  • Patients resuscitated after cardiac arrest
  • No Flow \< 10 min
  • Low Flow \< 20 min
  • Neutropenia \< 1 G/L
  • Post traumatic cardiac arrest
  • Contraindication of halogenated anesthesics
  • Extra corporeal life support or intra aortic balloon pump

You may not qualify if:

  • Pregnant woman
  • Hemodynamic instability
  • Brain death defined by the disappearance of brain stem reflexes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Sébastien PERBET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 25, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 14, 2025

Record last verified: 2021-05

Locations

FR(1)