CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 802 enrolled
Drug / intervention
Low normal MAP +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141099
NCT03141099N/ACompleted
CompareCT.gov

Blood Pressure and Oxygenation Targets in Post-resuscitation Care, a Randomized Clinical Trial

Jesper Kjaergaard·interventional·Posted May 4, 2017·Updated Jun 30, 2022

In Brief

A clinical study evaluating Low normal MAP, High normal MAP, and 2 other interventions for Out-of-Hospital Cardiac Arrest and 2 related conditions. Completed, enrolled 802 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOut-of-Hospital Cardiac Arrest, Blood Pressure, Hemodynamic Instability
CountriesDenmark
CollaboratorsOdense University Hospital

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 4, 2017
Enrollment StartMar 10, 2017
Primary CompletionDec 15, 2021
Study CompletionMar 15, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.2 years ago

Interventions

Low normal MAPother

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.

High normal MAPother

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.

Low normal PaO2.other

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

High normal PaO2other

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