Blood Pressure and OXygenation Targets After OHCA
NCT03141099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 802
Last updated 2022-06-30
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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