2024-515997-28-00招募中3 期
DANOHCA: The Danish Out-of-Hospital Cardiac Arrest study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 5
- 主要终点
- The protective effect of dexamethasone decided by all-cause mortality at 90 days following cardiac arrest
研究概览
简要总结
The coprimary objectives of the trial for the four interventions:
- Determine the efficacy of the glucocorticoid "dexamethasone "(Dexamethasone) compared with placebo. The primary endpoint is allcause mortality at 90 days
- Determine the efficacy of elevated backrest (30-45 degrees) compared with reclined (5-15 degrees) backrest. The primary endpoint is all-cause mortality at 90 days
- Determine the efficacy of early wake up and extubation ≤6 hours after admission compared with wake up and extubation at 28-36 hours. The primary endpoint is days alive outside hospital within 30 days
- Determine the efficacy of the antipsychotic drug "olanzapine"(Zyprexa) compared with placebo. The primary endpoint is days alive outside hospital within 30 days
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •OHCA of presumed cardiac cause
- •Sustained ROSC. Sustained ROSC is when chest compressions or mechanical circulatory support have been not required for 20 consecutive minutes and signs of circulation persist.
- •Unconsciousness (GCS <9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization
排除标准
- •Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)
- •Systolic blood pressure <80 mm Hg despite fluid loading/vasopressor and/or inotropic medication. If the systolic blood pressure (SBP) is recovering during the inclusion window (180 minutes) the patient may be included
- •Use of intra-aortic balloon pump/axial flow device/ECMO. If the patient is weaned and the device is removed during the inclusion window (180 minutes) the patient may be included
- •Temperature on admission <30°C
- •Known allergy from dexamethasone or olanzapine
- •Ongoing (within 48 h) treatment with dexamethasone or olanzapine
- •Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle
- •Known or suspected Long QT Syndrome (LQTS)
- •Known active fungal disease. Localized skin lesions do not exclude patients from inclusion
- •Estimated body weight <45kg
- •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 CPC 3 or 4 functional status
- •>3 hours (180 minutes) from ROSC to screening
结局指标
主要结局
The protective effect of dexamethasone decided by all-cause mortality at 90 days following cardiac arrest
The protective effect of dexamethasone decided by all-cause mortality at 90 days following cardiac arrest
The protective effect of elevated backrest (30-45 degrees) decided by all-cause mortality at 90 days following cardiac arrest
The protective effect of elevated backrest (30-45 degrees) decided by all-cause mortality at 90 days following cardiac arrest
The protective effect of early wake up and extubation ≤6 hours after admission decided by days alive outside hospital within 30 days
The protective effect of early wake up and extubation ≤6 hours after admission decided by days alive outside hospital within 30 days
The protective effect of olanzapine decided by days alive outside hospital within 30 days
The protective effect of olanzapine decided by days alive outside hospital within 30 days
次要结局
- All-cause mortality at 90 days (in study strata where it is not a primary endpoint)
- Serum Neuron Specific Enolase and Light Chain Neurofilament levels at 48h
- Markers of organ damage other than CNS: 1) TNT or TNI and CKMB (cardiac) and proBNP during initial 72h and 2) Creatinine during initial 72h and the use of dialysis during the first 30 days post OHCA (renal)
- Need for vasopressor during ICU stay. (cumulative doses during the first 36 hours and total doses)
- Mixed blood venous saturation after 12, 24 and 36 hours and the daily during ICU stay
- Duration of intubation (oral and tracheostomy combined)
- Number of unconscious patients at 96 hours
- Number of CAM-ICU positive patients 24 hours after extubation
- Number of CAM-ICU negative days
- Number of days without pharmacological treatment for delirium (other than study drug during the intervention period)
- ICU length of stay
- Hospital length of stay (including in-patient rehabilitation and transfer to referral hospital)
- CPC and mRS at ICU discharge, at hospital discharge and at 90 days
研究者
Christian Hingstrup Hassager
Scientific
Rigshospitalet
研究点 (5)
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