Hypertension, Pulmonary Arterial, Intensive Care Unit, Mechanical Ventilation, Out-Of-Hospital Cardiac Arrest, Oxygen Therapy, Resuscitation
Conditions
Keywords
Out-of-hospital cardiac arrest, Resuscitation, Oxygen, Intensive Care Unit, Mechanical ventilation, Pulmonary Hypertension
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.
Interventions
OTHERRestrictive PaO2
Patients are randomized to a PaO2 target of 9-10 kPa (open-label).
OTHERLow normal MAP
The patients are randomized to receive 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.
OTHERLiberal PaO2
Patients are randomized to a PaO2 target of 13-14 kPa (open-label).
OTHERHigh normal MAP
The patients are randomized to receive 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.
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The RELIEPH trial is a substudy of the BOX trial, which is a multicenter, randomised clinical trial with a 2x2 factorial design. Patients are allocated 1:1:1:1 to two interventions, respectively high- or low mean arterial pressures (double blinded) and restrictive- or liberal oxygenation (open label). The RELIEPH trial focuses on the oxygen intervention and only has access to data from one trial site. This makes the RELIEPH trial a single-center, parallel-group randomised controlled trial with patients allocated 1:1 to the oxygen target interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * OHCA of presumed cardiac cause * Sustained ROSC * Unconsciousness (Glasgow coma scale \<8) after sustained ROSC
Exclusion criteria
* Conscious patients (obeying verbal commands) * Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window) * In-hospital cardiac arrest * OHCA of presumed non-cardiac cause e.g. after trauma or dissection/rupture of major artery or cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging). * Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient) * Suspected or confirmed acute intracranial bleeding * Suspected or confirmed acute stroke * Unwitnessed asystole * Known limitations in therapy and Do Not Resuscitate-order * Known disease making 180 days survival unlikely * Known pre-arrest cerebral performance category 3 or 4 * \>4 hours (240 minutes) from ROSC to screening * Systolic blood pressure \<80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication/intra-aortic balloon pump/axial flow device * Temperature on admission \<30°C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary hypertension | Up to 30 days. | Fraction of time with pulmonary hypertension (mPAP \>25 mmHg) out of total time with mechanical ventilation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay. | Up to 8 weeks. | Length of ICU stay among survivors. |
| Lactate clearance. | 24 hours. | \>30% reduction in lactate level. |
| Right ventricular failure. | Up to 8 weeks. | Cardiac index \<2 and central venous pressure \>18 mmHg. |
| Mortality. | 30 days after ROSC. | Dead or alive. |
| Plasma brain natriuretic peptide. | 48 hours from randomisation. | Plasma brain natriuretic peptide level. |
Countries
Denmark
Contacts
Primary ContactMie Mørkøre, MS
Backup ContactRikke Ingerslev Stage, MS
Outcome results
None listed