Blood Pressure and OXygenation Targets After OHCA

NCT03141099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2022-06-30

No results posted yet for this study

Summary

This study compares two blood pressure targets and two oxygenation targets in the post-resuscitation care of comatose out-of-hospital cardiac arrets patients. Using a novel method the blood pressure-intervention is double-blinded. The oxygenation-intervention is open-label. As a subordinate study, the patients will be randomized 1:1 to active fever-control with an automated feedback temperature control-device for 36 or 72 hours following return of spontaneous circulation.

Conditions

  • Out-of-Hospital Cardiac Arrest
  • Blood Pressure
  • Hemodynamic Instability

Interventions

OTHER

Low normal MAP

The patients are randomized to recieve a Phillips M1006B blood pressure measuring module, offset by +10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 63 mmHg.

OTHER

High normal MAP

The patients are randomized to recieve a Phillips M1006B blood pressure measuring module, offset by -10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 77mmHg.

OTHER

Low normal PaO2.

The patients are randomized to a PaO2 target of 9-10 kPa (open-label).

OTHER

High normal PaO2

The patients are randomized to a PaO2 target of 13-14 kPa (open-label).

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER
  • Jesper Kjaergaard

    lead OTHER

Principal Investigators

  • Jesper Kjaergaard, Md, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2021-12-15
Completion
2022-03-15

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141099 on ClinicalTrials.gov