DEXAMETHASONE DISODIUM PHOSPHATE for Out-of-hospital cardiac arrest

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- OHCA of presumed cardiac cause\n- 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.\n- Unconsciousness (GCS <9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization"}

Exclusion criteria

• {"criterion_text":"- Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)\n- 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\n- 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\n- Temperature on admission <30°C\n- Known allergy from dexamethasone or olanzapine\n- Ongoing (within 48 h) treatment with dexamethasone or olanzapine\n- Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle\n- Known or suspected Long QT Syndrome (LQTS)\n- Known active fungal disease. Localized skin lesions do not exclude patients from inclusion\n- Estimated body weight <45kg\n- Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)\n- Suspected or confirmed acute intracranial bleeding\n- Suspected or confirmed acute stroke\n- Unwitnessed asystole\n- Known limitations in therapy and Do Not Resuscitate-order\n- Known disease making 180 days survival unlikely\n- Known pre-arrest CPC 3 or 4 functional status\n- >3 hours (180 minutes) from ROSC to screening"}

Primary endpoints

• {"endpoint_text":"- The protective effect of dexamethasone decided by all-cause mortality at 90 days following cardiac arrest","definition_or_measurement_approach":"All-cause mortality at 90 days following cardiac arrest (measured as death from any cause within 90 days)."}
• {"endpoint_text":"- The protective effect of elevated backrest (30-45 degrees) decided by all-cause mortality at 90 days following cardiac arrest","definition_or_measurement_approach":"All-cause mortality at 90 days following cardiac arrest (measured as death from any cause within 90 days) comparing elevated backrest (30-45°) vs reclined (5-15°)."}
• {"endpoint_text":"- The protective effect of early wake up and extubation ≤6 hours after admission decided by days alive outside hospital within 30 days","definition_or_measurement_approach":"Days alive outside hospital within 30 days (measured as the number of days the patient is alive and not admitted in hospital during the first 30 days post-intervention)."}
• {"endpoint_text":"- The protective effect of olanzapine decided by days alive outside hospital within 30 days","definition_or_measurement_approach":"Days alive outside hospital within 30 days (measured as the number of days the patient is alive and not admitted in hospital during the first 30 days post-intervention)."}

Secondary endpoints

• {"endpoint_text":"- All-cause mortality at 90 days (in study strata where it is not a primary endpoint)","definition_or_measurement_approach":"All-cause mortality at 90 days measured in strata where not used as primary endpoint."}
• {"endpoint_text":"- Serum Neuron Specific Enolase and Light Chain Neurofilament levels at 48h","definition_or_measurement_approach":"Biomarker measurements: Serum NSE and neurofilament light chain levels at 48 hours post-inclusion."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Laboratory markers during initial 72 hours (troponin/TNI, CKMB, proBNP, creatinine) and requirement for dialysis within 30 days."}
• {"endpoint_text":"- Need for vasopressor during ICU stay. (cumulative doses during the first 36 hours and total doses)","definition_or_measurement_approach":"Requirement for vasopressor therapy during ICU stay; cumulative doses during first 36 hours and total doses recorded."}
• {"endpoint_text":"- Mixed blood venous saturation after 12, 24 and 36 hours and the daily during ICU stay","definition_or_measurement_approach":"Mixed venous blood saturation measurements at 12, 24, 36 hours and daily during ICU stay."}
• {"endpoint_text":"- Duration of intubation (oral and tracheostomy combined)","definition_or_measurement_approach":"Total duration (days/hours) of invasive ventilation (oral and tracheostomy combined)."}
• {"endpoint_text":"- Number of unconscious patients at 96 hours","definition_or_measurement_approach":"Count of patients remaining unconscious at 96 hours post-inclusion."}
• {"endpoint_text":"- Number of CAM-ICU positive patients 24 hours after extubation","definition_or_measurement_approach":"Number of patients scoring CAM-ICU positive 24 hours after extubation."}
• {"endpoint_text":"- Number of CAM-ICU negative days","definition_or_measurement_approach":"Number of days with CAM-ICU negative assessments."}
• {"endpoint_text":"- Number of days without pharmacological treatment for delirium (other than study drug during the intervention period)","definition_or_measurement_approach":"Days without pharmacologic delirium treatment during intervention period (excluding study drug)."}
• {"endpoint_text":"- ICU length of stay","definition_or_measurement_approach":"Duration of ICU stay measured in days."}
• {"endpoint_text":"- Hospital length of stay (including in-patient rehabilitation and transfer to referral hospital)","definition_or_measurement_approach":"Total hospital length of stay including in-patient rehabilitation and transfers, measured in days."}
• {"endpoint_text":"- CPC and mRS at ICU discharge, at hospital discharge and at 90 days","definition_or_measurement_approach":"Cerebral Performance Category (CPC) and modified Rankin Scale (mRS) assessments at ICU discharge, hospital discharge and at 90 days."}

Denmark

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

01-10-2025

Processing Time Days

364

Number Of Sites

5

Number Of Participants

1000

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsor duties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsor duties code: 1","organisation_type":"Educational Institution"}