Study on the Effects of Dexamethasone and Olanzapine in Patients Resuscitated from Out-of-Hospital Cardiac Arrest

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What is this study about?

The Danish Out-of-Hospital Cardiac Arrest study, known as DANOHCA, is focused on patients who have been resuscitated after experiencing a cardiac arrest outside of a hospital. This study is exploring the effects of different treatments and approaches to improve recovery and survival. One of the treatments being studied is the use of the glucocorticoid dexamethasone, which is compared to a placebo. Another treatment involves the use of the antipsychotic drug olanzapine, also compared to a placebo. The study aims to determine how these treatments affect survival and recovery after cardiac arrest.

Participants in the study will receive either the active medication or a placebo, and their progress will be monitored over a period of time. The study will also look at the effects of different physical positions, such as an elevated backrest, and the timing of waking up and removing breathing support after admission to the hospital. The main goal is to see how these interventions impact the number of days patients are alive outside the hospital within 30 days and overall survival at 90 days.

This study is important for understanding how to best support patients who have suffered a cardiac arrest outside of a hospital setting. By comparing these different treatments and approaches, researchers hope to find ways to improve outcomes and quality of life for these patients. The results could lead to better treatment guidelines and care practices for individuals recovering from cardiac arrest.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, the occurrence of an out-of-hospital cardiac arrest, and sustained return of spontaneous circulation (ROSC).

2 randomization

Participants are randomly assigned to different groups to receive specific interventions. This ensures that the study results are unbiased and reliable.

3 medication administration

Depending on the group assignment, participants may receive the medication dexamethasone or a placebo through intravenous use. The purpose is to evaluate the medication’s effect on survival rates 90 days after cardiac arrest.

Another group may receive the medication olanzapine or a placebo in the form of orodispersible tablets, which dissolve in the mouth. This is to assess the impact on the number of days alive outside the hospital within 30 days.

4 positioning intervention

Participants may be placed in a bed with an elevated backrest (30-45 degrees) or a reclined backrest (5-15 degrees) to determine the effect on survival rates 90 days after cardiac arrest.

5 wake-up and extubation

Participants may undergo early wake-up and removal of the breathing tube within 6 hours after admission or later, between 28-36 hours. This is to evaluate the effect on the number of days alive outside the hospital within 30 days.

6 monitoring and follow-up

Throughout the trial, various health markers are monitored, including organ function and inflammation levels. This helps assess the overall impact of the interventions.

Participants’ health status is followed up for 90 days to evaluate survival rates and quality of life.

Who Can Join the Study?

Must be at least 18 years old.
Must have experienced an out-of-hospital cardiac arrest (heart stopped beating outside of a hospital) that is believed to be due to heart-related issues.
Must have achieved sustained ROSC (Return of Spontaneous Circulation), which means the heart started beating on its own again without needing chest compressions or mechanical support for at least 20 minutes, and signs of circulation are present.
Must be unconscious (not able to follow verbal commands) after achieving sustained ROSC at the time of being selected for the study. This is measured by a Glasgow Coma Scale (GCS) score of less than 9, which is a scale used to assess consciousness.

Who Cannot Join the Study?

Patients who have not been resuscitated from an out-of-hospital cardiac arrest cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Region Sjaelland	Holbæk	Denmark
Alhwgk Uxsxwztlki Hcqpbgzf	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.03.2023

Trial locations

Investigated drugs:

Dexamethasone is a type of medication known as a glucocorticoid. It is often used to reduce inflammation and suppress the immune system. In this clinical trial, it is being tested to see if it can help improve survival rates in patients who have experienced a cardiac arrest outside of a hospital setting. The main goal is to determine if patients who receive dexamethasone have a lower risk of death within 90 days compared to those who do not receive it.

The trial also involves a non-medication therapy where patients are positioned with an elevated backrest, set at an angle between 30 to 45 degrees. This is being compared to a more reclined position, with the backrest at 5 to 15 degrees. The purpose of this intervention is to see if the position of the backrest can affect the survival rates of patients after a cardiac arrest.

Another therapy being tested is the timing of waking up and removing the breathing tube (extubation) for patients. One group of patients will be woken up and have their breathing tube removed within 6 hours after being admitted to the hospital, while another group will have this done between 28 to 36 hours. The trial aims to find out if earlier wake-up and extubation can lead to more days alive outside the hospital within 30 days.

Olanzapine, also known by the brand name Zyprexa, is an antipsychotic medication. It is typically used to treat mental health conditions like schizophrenia and bipolar disorder. In this study, it is being tested to see if it can help improve outcomes for patients who have had a cardiac arrest. The researchers want to find out if patients who receive olanzapine have more days alive outside the hospital within 30 days compared to those who do not receive it.

Cardiac Arrest – Cardiac arrest is a sudden loss of heart function, leading to a cessation of blood flow to the body. It occurs when the heart’s electrical system malfunctions, causing an irregular heartbeat or stopping the heart entirely. This condition can happen unexpectedly and requires immediate medical attention. During cardiac arrest, the brain and other vital organs are deprived of oxygen, which can lead to severe damage. If not treated promptly, it can result in unconsciousness and potential long-term complications. Recovery depends on the speed and effectiveness of the resuscitation efforts.

Trial ID:

2024-515997-28-00

Protocol code:

DANOHCA-001

NCT ID:

NCT05895838

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Dexamethasone and Olanzapine in Patients Resuscitated from Out-of-Hospital Cardiac Arrest

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?