The Danish Out-of-Hospital Cardiac Arrest study (DANOHCA)

The Danish Out-of-Hospital Cardiac Arrest study (DANOHCA) - The DANOHCA study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005876-21-DK

Enrollment

1000

Registered

2021-12-20

Start date

2022-07-08

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We will investigate the efficacy of four interventions (two pharmaceutical) for reducing mortality and organ damage in patients resuscitated after out-of-hospital cardiac arrest. MedDRA version: 20.0 Level: LLT Classification code 10003109 Term: Arrest cardiac System Organ Class: 100000004849

Interventions

Trade Name: Dexavit Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone phosphate CAS Number: 312-93-6 Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. OHCA of presumed cardiac cause 3. Sustained ROSC# 4. Unconsciousness (GCS =65 years) yes F.1.3.1 Number of subjects for this age range 700

Exclusion criteria

Exclusion criteria: 1. Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window) 2. Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient) 3. Suspected or confirmed acute intracranial bleeding 4. Suspected or confirmed acute stroke 5. Unwitnessed asystole 6. Known limitations in therapy and Do Not Resuscitate-order 7. Known disease making 180 days survival unlikely 8. Known pre-arrest CPC 3 or 4 functional status 9. >3 hours (180 minutes) from ROSC to screening 10. Systolic blood pressure <80 mm Hg despite fluid loading/vasopressor and/or inotropic medication# 11. Use of intra-aortic balloon pump/axial flow device/ECMO† 12. Temperature on admission <30°C Further exclusion criteria specific to the trial interventions: 13. Known allergy from dexamethasone or olanzapine 14. Ongoing (within 48 h) treatment with dexamethasone or olanzapine 15. Known back or hip condition that precluded the patients from being positioned with backrest from 5 to 35-degree angle 16. Known or suspected Long QT Syndrome (LQTS) 17. Known active fungal disease. Localized skin lesions do not exclude patients from inclusion 18. Estimated body weight <45kg # If the systolic blood pressure (SBP) is recovering during the inclusion window (180 minutes) the patient may be included † If the patient is weaned and the device is removed during the inclusion window (180 minutes) the patient may be included

Design outcomes

Primary

Measure	Time frame
Main Objective: The coprimary objectives of the trial for the four interventions: 1. Determine the efficacy of the glucocorticoid "dexamethasone" (Dexamethasone) compared with placebo. The primary endpoint is all-cause mortality at 90 days 2. Determine the efficacy of elevated backrest (35 degrees) compared with reclined (5 degrees) backrest. The primary endpoint is all-cause mortality at 90 days 3. 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 4. Determine the efficacy of the antipsychotic drug "olanzapine" compared with placebo. The primary endpoint is days alive outside hospital within 30 days;Secondary Objective: The secondary and tertiary objectives of the trial are to investigate the effects of the interventions on inhibition of inflammation, cardiac protection, neuroprotection, renal protection, endothelial protection, clinical endpoints including survival and neurological outcome, as well as safety.;Primary end point(s): 1. The protective effect of dexamethasone decided by all-cause mortality at 90 days following cardiac arrest 2. The protective effect of elevated backrest (35 degrees) decided by all-cause mortality at 90 days following cardiac arrest 3. The protective effect of early wake up and extubation =6 hours after admission decided by days alive outside hospital within 30 days 4. The protective effect of olanzapine decided by days alive outside hospital within 30 days;Timepoint(s) of evaluation of this end point: 1. At 90 days following cardiac arrest (Dexamethasone) 2. At 90 days following cardiac arrest (Elevated backrest) 3. Days alive outside hospital within 30 days (Early wake up) 4. Days alive outside hospital within 30 days (Olanzapine)	—

Measure

Time frame

Main Objective: The coprimary objectives of the trial for the four interventions: 1. Determine the efficacy of the glucocorticoid "dexamethasone" (Dexamethasone) compared with placebo. The primary endpoint is all-cause mortality at 90 days 2. Determine the efficacy of elevated backrest (35 degrees) compared with reclined (5 degrees) backrest. The primary endpoint is all-cause mortality at 90 days 3. 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 4. Determine the efficacy of the antipsychotic drug "olanzapine" compared with placebo. The primary endpoint is days alive outside hospital within 30 days;Secondary Objective: The secondary and tertiary objectives of the trial are to investigate the effects of the interventions on inhibition of inflammation, cardiac protection, neuroprotection, renal protection, endothelial protection, clinical endpoints including survival and neurological outcome, as well as safety.;Primary end point(s): 1. The protective effect of dexamethasone decided by all-cause mortality at 90 days following cardiac arrest 2. The protective effect of elevated backrest (35 degrees) decided by all-cause mortality at 90 days following cardiac arrest 3. The protective effect of early wake up and extubation =6 hours after admission decided by days alive outside hospital within 30 days 4. The protective effect of olanzapine decided by days alive outside hospital within 30 days;Timepoint(s) of evaluation of this end point: 1. At 90 days following cardiac arrest (Dexamethasone) 2. At 90 days following cardiac arrest (Elevated backrest) 3. Days alive outside hospital within 30 days (Early wake up) 4. Days alive outside hospital within 30 days (Olanzapine)

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Secondary

Measure	Time frame
Secondary end point(s): 1. All-cause mortality at 90 days (in study strata where it is not a primary endpoint) 2. Serum Neuron Specific Enolase46 and Neurofilament Light Chain levels47 at 48h 3. Markers of cardiac and kidney injury: TNT or TNI and CKMB and proBNP (cardiac) during initial 72h and creatinine during initial 72h and the use of dialysis during the first 30 days post OHCA (kidney) 4. Need for vasopressor during ICU stay (cumulative doses during the first 36 hours and total doses) 5. Mixed blood venous saturation after 12, 24 and 36 hours and the daily during ICU stay 6. Duration of intubation (oral and tracheostomy combined) 7. Number of unconscious patients at 96 hours 8. Number of CAM-ICU positive patients 24 hours after extubation 9. Number of CAM-ICU negative days 10. Number of days without pharmacological treatment for delirium (other than study drug during the intervention period) 11. ICU length of stay 12. Hospital length of stay (including in-patient rehabilitation and transfer to referral hospital) 13. CPC and mRS at ICU discharge, at hospital discharge, and at 90 days (assessed at ambulatory follow-up) Common tertiary endpoints to all four interventions: These tertiary endpoints are expected to form the basis for sub-studies and the randomization code will possibly have been broken and main results published prior to their collection. 1. All-cause mortality at 180 days 2. Inflammatory and organ markers during initial 72 hours measured as part of routine biochemistry, including CRP, leukocytes, platelets, liver enzymes, and coagulation test, as well as markers measured on biobank samples which will include a panel of cytokines, additional inflammatory markers, and markers of organ injury. 3. Capture of results from standard biochemistry performed as part of standard of care for initial 7 days including CRP, leukocytes, platelets, liver enzymes, bilirubin, electrolytes, and coagulation test. 4. Positive blood cultures taken on clinical indicati	—

Measure

Time frame

Secondary end point(s): 1. All-cause mortality at 90 days (in study strata where it is not a primary endpoint) 2. Serum Neuron Specific Enolase46 and Neurofilament Light Chain levels47 at 48h 3. Markers of cardiac and kidney injury: TNT or TNI and CKMB and proBNP (cardiac) during initial 72h and creatinine during initial 72h and the use of dialysis during the first 30 days post OHCA (kidney) 4. Need for vasopressor during ICU stay (cumulative doses during the first 36 hours and total doses) 5. Mixed blood venous saturation after 12, 24 and 36 hours and the daily during ICU stay 6. Duration of intubation (oral and tracheostomy combined) 7. Number of unconscious patients at 96 hours 8. Number of CAM-ICU positive patients 24 hours after extubation 9. Number of CAM-ICU negative days 10. Number of days without pharmacological treatment for delirium (other than study drug during the intervention period) 11. ICU length of stay 12. Hospital length of stay (including in-patient rehabilitation and transfer to referral hospital) 13. CPC and mRS at ICU discharge, at hospital discharge, and at 90 days (assessed at ambulatory follow-up) Common tertiary endpoints to all four interventions: These tertiary endpoints are expected to form the basis for sub-studies and the randomization code will possibly have been broken and main results published prior to their collection. 1. All-cause mortality at 180 days 2. Inflammatory and organ markers during initial 72 hours measured as part of routine biochemistry, including CRP, leukocytes, platelets, liver enzymes, and coagulation test, as well as markers measured on biobank samples which will include a panel of cytokines, additional inflammatory markers, and markers of organ injury. 3. Capture of results from standard biochemistry performed as part of standard of care for initial 7 days including CRP, leukocytes, platelets, liver enzymes, bilirubin, electrolytes, and coagulation test. 4. Positive blood cultures taken on clinical indicati

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Countries

Denmark

Contacts

Public ContactDepartment of Cardiology

Copenhagen University Hospital, Rigshospitalet

christian.hassager@regionh.dk4535450572

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026