Health Trials

Stepcare Extended Follow-up Substudy

ConditionsCardiac Arrest With Successful ResuscitationHypoxia, BrainCognitive ImpairmentCaregiver Burden
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of <4, or being intubated and sedated because of agitation after sustained ROSC, eligible for intensive care without restrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable ROSC).

Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomized in the STEPCARE trial.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Feed back controlled temperature device

    Device

    If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius

  • High MAP

    Other intervention

    A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours

  • Deep sedation

    Other intervention

    Deep sedation for at least 36 hours

  • Fever control without a device

    Other intervention

    Management of fever in the intensive care unit without a device

  • Low MAP

    Other intervention

    A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours

  • Minimal sedation

    Other intervention

    A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures

Treatment groups

600 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Sedation, temperature device and high MAPActive comparator 3 interventions
Group B: Sedation, no temperature device and high MAPActive comparator 3 interventions
Group C: Sedation, temperature device and low MAPActive comparator 3 interventions
Group D: Sedation, no temperature device, and low MAPActive comparator 3 interventions
Group E: Minimal sedation, temperature device, and high MAPActive comparator 3 interventions
Group F: Minimal sedation, no temperature device and high MAPActive comparator 3 interventions
Group G: Minimal sedation, temperature device and low MAPActive comparator 3 interventions
Group H: Minimal sedation, no temperature device and low MAPActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Montreal Cognitive Assessment (MoCA)

Cognitive function for out of hospital cardiac arrest survivors. Score range. Higher scores=better cognition

Time frame
6 months
2

Zarit Burden Interview (ZBI)

Caregiver burden for caregivers to out of hospital cardiac arrest survivors. Score range 0-88. Higher scores= worse indicating more caregiver burden

Time frame
6 months

Secondary outcomes

Other outcomes

1

Symbol Digit Modalities Test (SDMT)

Processing speed. For out of hospital cardiac arrest survivors. Scores presented as age and education adjusted z-scores. Higher scores=better

Time frame
6 and 12 months
2

Hospital Anxiety and Depression Scale (HADS)

Symptoms of anxiety and depression. For both out of hospital cardiac arrest survivors and caregivers. Score range 0-21 for anxiety and depression respectively. Higher scores=worse and incerased symptoms of anxiety and depression

Time frame
6 and 12 months
3

Post Posttraumatic Stress Disorders Checklist updated for DSM-5 (PCL-5)

Symptoms of posttraumatic stress. For both out of hospital cardiac arrest survivors and caregivers. Score range 0-80. Higher scores=worse indicating increased symptoms of PTSD

Time frame
6 and 12 months
4

Modified Fatigue Impact Scale (MFIS)

Impact of fatigue. For out of hospital cardiac arrest survivors. Score range 0-84. Higher scores= worse indicating more problems with impact of fatigue

Time frame
6 and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Skane

Lead sponsor

Lund University

Collaborator

The George Institute for Global Health, Australia

Collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborator

Helsinki University Central Hospital

Collaborator

Source ClinicalTrials.gov
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