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
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pulmonary hypertension
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •OHCA of presumed cardiac cause
- •Sustained ROSC
- •Unconsciousness (Glasgow coma scale <8) after sustained ROSC
排除标准
- •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
研究组 & 干预措施
Restrictive PaO2 and low normal MAP
Patients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: Restrictive PaO2 (Other)
Restrictive PaO2 and low normal MAP
Patients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: Low normal MAP (Other)
Restrictive PaO2 and high normal MAP
Patients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: Restrictive PaO2 (Other)
Restrictive PaO2 and high normal MAP
Patients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: High normal MAP (Other)
Liberal PaO2 and low normal MAP
Patients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: Low normal MAP (Other)
Liberal PaO2 and low normal MAP
Patients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: Liberal PaO2 (Other)
Liberal PaO2 and high normal MAP
Patients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: Liberal PaO2 (Other)
Liberal PaO2 and high normal MAP
Patients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA.
干预措施: High normal MAP (Other)
结局指标
主要结局
Pulmonary hypertension
时间窗: Up to 30 days.
Fraction of time with pulmonary hypertension (mPAP \>25 mmHg) out of total time with mechanical ventilation.
次要结局
- Right ventricular failure.(Up to 8 weeks.)
- Mortality.(30 days after ROSC.)
- Plasma brain natriuretic peptide.(48 hours from randomisation.)
- Length of ICU stay.(Up to 8 weeks.)
- Lactate clearance.(24 hours.)