Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05029167
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2021-08-11
Brief Title:
REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest RELIEPH-study
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest RELIEPH-study a Substudy Protocol for a Randomised Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELIEPH
Brief Summary:
Background For patients with out-of-hospital cardiac arrest OHCA at the intensive care unit ICU oxygen therapy plays an important role in post resuscitation care During hospitalisation a lot of these patients occur with pulmonary arterial hypertension PAH Currently a wide oxygen target is recommended but no evidence regarding optimal treatment targets to minimise the prevalence of PAH exists
Methods The RELIEPH trial is a substudy within the BOX Blood pressure and OXygenation targets in post resuscitation care trial It is a single-center parallel-group randomised controlled clinical trial 300 patients with OHCA hospitalised at the ICU are allocated to one of the two oxygenation interventions either a restrictive- 9-10 kPa or liberal 13-14 kPa oxygen target both within the recommended range The primary outcome is the fraction of time with pulmonary hypertension mPAP 25 mmHg out of total time with mechanical ventilation Secondary outcomes are length of ICU stay among survivors lactate clearance right ventricular failure 30 days mortality and plasma brain natriuretic peptide BNP level 48 hours from randomisation
Discussion This study hypothesises that a liberal target of oxygen reduces the time with PAH during mechanical ventilation compared to a restrictive oxygen target in patients with OHCA at the ICU When completed this study hopes to provide new knowledge regarding which oxygen target is beneficial for this group of patients
Methods The RELIEPH trial is a substudy within the BOX Blood pressure and OXygenation targets in post resuscitation care trial It is a single-center parallel-group randomised controlled clinical trial 300 patients with OHCA hospitalised at the ICU are allocated to one of the two oxygenation interventions either a restrictive- 9-10 kPa or liberal 13-14 kPa oxygen target both within the recommended range The primary outcome is the fraction of time with pulmonary hypertension mPAP 25 mmHg out of total time with mechanical ventilation Secondary outcomes are length of ICU stay among survivors lactate clearance right ventricular failure 30 days mortality and plasma brain natriuretic peptide BNP level 48 hours from randomisation
Discussion This study hypothesises that a liberal target of oxygen reduces the time with PAH during mechanical ventilation compared to a restrictive oxygen target in patients with OHCA at the ICU When completed this study hopes to provide new knowledge regarding which oxygen target is beneficial for this group of patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None