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Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE)
Sponsor: Helsinki University Central Hospital
Summary
The STEPCARE-MAKE study is a predefined sub-study of the large Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, which evaluates the effects of three interventions in comatose adult patients resuscitated from out-of-hospital cardiac arrest. In this sub-study, all 3500 participants enrolled in the main trial are assessed for major adverse kidney events (MAKE) and creatinine kinetics.
Official title: Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE): a Protocol for a Pre-planned Sub-study of a Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3500
Start Date
2023-08-17
Completion Date
2026-12
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
Feedback-controlled temperature device
If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C
High MAP
A MAP target of \>85mmHg will be used. Vasopressors will be titrated to this target during 36h
Deep sedation
Deep sedation for at least 36h
Fever control without a device
Management of fever in the ICU without a device
Low MAP
A MAP target of \>65mmHg will be used. Vasopressors will be titrated to this target during 36h
Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Locations (52)
Princess Alexandra Hospital
Brisbane, Australia
The Prince Charles Hospital
Brisbane, Australia
Nepean Hospital
Kingswood, Australia
Liverpool Hospital
Liverpool, Australia
Austin Hospital
Melbourne, Australia
Royal North Shore Hospital
Sydney, Australia
St George Hospital
Sydney, Australia
The Sutherland Hospital
Sydney, Australia
HUB Hôpital Erasme
Brussels, Belgium
Ghent University Hospital
Ghent, Belgium
Ziekenhuis Oost-Limburg Hospital
Lanaken, Belgium
North Estonia Medical Centre
Tallinn, Estonia
Jorvi Hospital
Espoo, Finland
Meilahti Hospital
Helsinki, Finland
Jyväskylä Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Charite University Hospital
Berlin, Germany
Lübeck University Hospital
Lübeck, Germany
Tubingen University Hospital
Tübingen, Germany
San Martino Hospital Genova
Genova, Italy
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg
DCCM ICU
Auckland, New Zealand
Middlemore ICU
Auckland, New Zealand
North Shore ICU NZ
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Wellington Hospital
Wellington, New Zealand
Soerlandet Hospital Arendal
Arendal, Norway
Kalnes Hospital
Grålum, Norway
Oslo University Hospital
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
King Abdulaziz Medical City
Riyadh, Saudi Arabia
Tan Tock Seng Hospital
Singapore, Singapore
Sahlgrenska University Hospital
Gothenburg, Sweden
Hallands hospital
Halmstad, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Karlstad hospital
Karlstad, Sweden
Skåne University Hospital
Lund, Sweden
Skåne University Hospital Malmö
Malmö, Sweden
Skaraborg Hospital Skovde
Skövde, Sweden
Karolinska University Hospital
Stockholm, Sweden
University Hospital of Umeå
Umeå, Sweden
Bern University Hospital
Bern, Switzerland
St Gallen Hospital
Sankt Gallen, Switzerland
University Hospital Zürich
Zurich, Switzerland
Essex Cardiothoracic Centre
Basildon, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Cardiff University Hospital
Cardiff, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Kings College Hospita
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
St Georges University Hospital
London, United Kingdom