Stepcare Extended Follow-up Substudy

Official title

Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial

Overview

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.

Detailed description

This extended follow-up substudy is incorporated into the multi-center, international, factorial randomized Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation -STEPCARE trial (Clinical trials identifier:NCT05564754) were out of hospital cardiac arrest participants will be randomized to different targets of sedation, temperature, and MAP management.

Only selected STEPCARE sites will participate in this extended follow-up substudy. At the extended follow up participating sites all out of hospital cardiac arrest participants randomized in the STEPCARE trial, who survive and provide consent, will be eligible to participate in this substudy, with no further inclusion or exclusion criteria.The extended follow-up substudy is estimated to enroll approximately 600 post OHCA survivors. One nominated caregiver per post OHCA survivor will be invited to be included in the study.

Participants will be followed up at 6 and 12 months.

The primary outcome for this extended follow up substudy is cognitive function at 6 months for the out of hospital cardiac arrest survivors andCaregiver burden at 6 months for the caregivers.

Interventions

• Device Feed back controlled temperature device
  If core temperature exceeds 37.7 degrees celsius a feedback controlled-device will be used at set to 37.5 degrees celsius
• Other High MAP
  A mean arterial blood pressure (MAP) of \>85mmHg will be used. Vasopressors will be titrated to this target during 36 hours
• Other Deep sedation
  Deep sedation for at least 36 hours
• Other Fever control without a device
  Management of fever in the intensive care unit without a device
• Other Low MAP
  A mean arterial blood pressure (MAP) of \>65mmHG will be used. Vasopressors will be titrated to this target during 36 hours
• Other Minimal sedation
  A strategy of minimal sedation in the intensive care unit, used only as needed to facilitate transport, imaging and invasive procedures

Primary outcome measures

• Montreal Cognitive Assessment (MoCA) [Time frame: 6 months]
• Zarit Burden Interview (ZBI) [Time frame: 6 months]

Eligibility criteria

All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or exclusion criteria.

The inclusion and exclusion criteria for the STEPCARE trial are:

• 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.

For caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Triple blind

Primary purpose

Treatment

Study locations

Australia · 8 centers

• Princess Alexandra Hospital — Brisbane
• The Sutherland Hospital — Caringbah
• The Prince Charles Hospital — Chermside
• Nepean hospital — Kingswood
• St George hospital — Kogarah
• Liverpool hospital — Liverpool
• Austin hospital — Melbourne
• Royal North Shore Hospital — Sydney

Sweden · 5 centers

• Sahlgrenska university hospital — Gothenburg
• Hallands hospital — Hålland
• Helsingborg hospital — Helsingborg
• Skåne university hospital — Lund
• Skåne university hopsital — Malmö

New Zealand · 4 centers

• Auckland city hospital — Auckland
• Middlemore hospital — Auckland
• Christchurch hospital — Christchurch
• Wellington hospital — Wellington

United Kingdom · 4 centers

• The Essex Cardiothoracic Centre — Basildon
• Bristol Royal Infirmary — Bristol
• University hospital of Wales — Cardiff
• St Bartholomew's hospital — London

Finland · 3 centers

• Helsinki Helsingfors university central hospital — Helsinki
• Jorvi hospital — Jorvi
• Tampere university hospital — Tampere

Germany · 3 centers

• Charite university hospital — Berlin
• Universitäres Herzzentrum Lübeck Universitätsklinikum Schleswig-Holstein — Lübeck
• Tubingen university hospital — Tübingen

Belgium · 2 centers

• Ziekenhuis Oost Limburg — Genk
• Ghent university hospital — Ghent

Norway · 2 centers

• Sorlandet hospital — Arendal
• Oslo university hospital Rikshospitalet — Oslo

Switzerland · 2 centers

• Bern university hospital — Bern
• Kantonsspital St. Gallen — Sankt Gallen

Luxembourg · 1 center

• Centre Hospitalier de Luxembourg — Luxembourg

Identifiers

NCT: NCT06207942 · extfustep2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗