Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE) (STEPCARE-MAKE)

29 de mayo de 2026 actualizado por: Miikka Keski-Keturi, Helsinki University Central Hospital

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

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The main STEPCARE trial randomizes patients to three different interventions: (1) continuous deep sedation for 36 hours or minimal sedation (with extubation if feasible), (2) fever control with or without a feedback-controlled device if the temperature rises above 37.7°C, and (3) a mean arterial pressure (MAP) target of ≥65 mmHg or ≥85 mmHg.

This sub-study evaluates the effects of these three interventions on major adverse kidney events (MAKE), defined as a composite of death within 30 days, initiation of renal replacement therapy during the stay in the primary hospital, or persistent renal dysfunction, defined as a final creatinine value ≥200% of baseline at the time of discharge from the primary hospital.

Creatinine kinetics during the stay in the primary hospital and within 72 hours post-resuscitation are evaluated as secondary outcomes.

All data are collected prospectively as part of the main trial protocol, and analyses will be conducted according to a predefined statistical analysis plan.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

3500

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
        • Charite University Hospital
      • Lübeck, Alemania
        • Lübeck University Hospital
      • Tübingen, Alemania
        • Tubingen University Hospital
  • Arabia Saudita
      • Riyadh, Arabia Saudita
        • King Abdulaziz Medical City
  • Australia
      • Brisbane, Australia
        • Princess Alexandra Hospital
      • Brisbane, Australia
        • The Prince Charles Hospital
      • Kingswood, Australia
        • Nepean Hospital
      • Liverpool, Australia
        • Liverpool Hospital
      • Melbourne, Australia
        • Austin Hospital
      • Sydney, Australia
        • Royal North Shore Hospital
      • Sydney, Australia
        • St George Hospital
      • Sydney, Australia
        • The Sutherland Hospital
  • Bélgica
      • Brussels, Bélgica
        • HUB Hôpital Erasme
      • Ghent, Bélgica
        • Ghent University Hospital
      • Lanaken, Bélgica
        • Ziekenhuis Oost-Limburg Hospital
  • Estonia
      • Tallinn, Estonia
        • North Estonia Medical Centre
  • Finlandia
      • Espoo, Finlandia
        • Jorvi Hospital
      • Helsinki, Finlandia, 00290
        • Meilahti Hospital
      • Jyväskylä, Finlandia
        • Jyväskylä Hospital
      • Kuopio, Finlandia
        • Kuopio University Hospital
      • Oulu, Finlandia
        • Oulu University Hospital
  • Italia
      • Genova, Italia
        • San Martino Hospital Genova
  • Luxemburgo
      • Luxembourg, Luxemburgo
        • Centre Hospitalier de Luxembourg
  • Noruega
      • Arendal, Noruega
        • Soerlandet Hospital Arendal
      • Grålum, Noruega
        • Kalnes Hospital
      • Oslo, Noruega
        • Oslo University Hospital
      • Stavanger, Noruega
        • Stavanger University Hospital
  • Nueva Zelanda
      • Auckland, Nueva Zelanda
        • DCCM ICU
      • Auckland, Nueva Zelanda
        • Middlemore ICU
      • Auckland, Nueva Zelanda
        • North Shore ICU NZ
      • Christchurch, Nueva Zelanda
        • Christchurch Hospital
      • Wellington, Nueva Zelanda
        • Wellington Hospital
  • Reino Unido
      • Basildon, Reino Unido
        • Essex cardiothoracic centre
      • Bristol, Reino Unido
        • Bristol Royal Infirmary
      • Cardiff, Reino Unido
        • Cardiff University Hospital
      • Leeds, Reino Unido
        • Leeds General Infirmary
      • London, Reino Unido
        • St Bartholomew's Hospital
      • London, Reino Unido
        • St Georges University Hospital
      • London, Reino Unido
        • Kings College Hospita
  • Singapur
      • Singapore, Singapur
        • Tan Tock Seng Hospital
  • Suecia
      • Gothenburg, Suecia
        • Sahlgrenska University Hospital
      • Halmstad, Suecia
        • Hallands hospital
      • Helsingborg, Suecia
        • Helsingborg Hospital
      • Karlstad, Suecia
        • Karlstad Hospital
      • Lund, Suecia
        • Skane University Hospital
      • Malmö, Suecia
        • Skåne University Hospital Malmö
      • Skövde, Suecia
        • Skaraborg Hospital Skovde
      • Stockholm, Suecia
        • Karolinska University Hospital
      • Umeå, Suecia
        • University Hospital of Umeå
  • Suiza
      • Bern, Suiza
        • Bern University Hospital
      • Sankt Gallen, Suiza
        • St Gallen Hospital
      • Zurich, Suiza
        • University Hospital Zurich

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • All patients included to the main STEPCARE-trial are also included to this substudy
  • Out-of-hospital cardiac arrest
  • Sustained return of spontaneous circulation, defined as 20 minutes with signs of circulation without the need for chest compressions
  • Unconsciousness (FOUR-score motor response <4, inability to obey verbal commands), or being intubated and sedated due to agitation
  • Eligible for intensive care without restrictions or limitations
  • Inclusion within 4 hours of the return of spontaneous circulation

Exclusion Criteria:

  • Out-of-hospital cardiac arrest of presumed traumatic or hemorrhagic origin
  • Confirmed or suspected intracranial hemorrhage
  • Pregnancy
  • Extracorporeal membrane oxygenation (ECMO) prior to randomization
  • No additional exclusion criteria are applied beyond those of the main STEPCARE trial

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Sedation, temperature device and high MAP
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
Otro: Sedación profunda
Sedación profunda durante al menos 36h
Dispositivo: 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
Otro: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparador activo: Sedation, no temperature device and high MAP
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥85mmHg
Otro: Sedación profunda
Sedación profunda durante al menos 36h
Otro: Control de fiebre sin dispositivo
Manejo de la fiebre en la UCI sin dispositivo
Otro: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparador activo: Sedation, temperature device and low MAP
Continuous deep sedation for 36 hours, fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
Otro: Sedación profunda
Sedación profunda durante al menos 36h
Dispositivo: 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
Otro: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparador activo: Sedation, no temperature device and low MAP
Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Otro: Sedación profunda
Sedación profunda durante al menos 36h
Otro: Control de fiebre sin dispositivo
Manejo de la fiebre en la UCI sin dispositivo
Otro: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Comparador activo: Minimal sedation, temperature device and high MAP
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥85mmHg
Dispositivo: 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
Otro: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Otro: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Comparador activo: Minimal sedation, no temperature device and high MAP
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Otro: Control de fiebre sin dispositivo
Manejo de la fiebre en la UCI sin dispositivo
Otro: High MAP
A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h
Otro: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Comparador activo: Minimal sedation, temperature device and low MAP
Minimal sedation (and early extubation if possible), fever management with a feedback-controlled device if temperature rises above 37.7°C and a mean arterial pressure target of ≥65mmHg
Dispositivo: 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
Otro: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Otro: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures
Comparador activo: Minimal sedation, no temperature device and low MAP
Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg
Otro: Control de fiebre sin dispositivo
Manejo de la fiebre en la UCI sin dispositivo
Otro: Low MAP
A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h
Otro: Minimal sedation
A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Major adverse kidney event (MAKE)
Periodo de tiempo: 30 days
A composite endpoint of MAKE: death from any cause by day 30, initiation of RRT during the stay in the primary hospital or persistent renal dysfunction defined as final creatinine value ≥200 % of the baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) at the time of discharge from the primary hospital
30 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference between baseline and the highest in-hospital creatinine
Periodo de tiempo: During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest in-hospital creatinine
During the stay in the index hospital following cardiac arrest, until discharge or transfer to another hospital, and within 30 days
Difference between baseline and the last measured in-hospital creatinine
Periodo de tiempo: At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the last measured in-hospital creatinine (in the primary hospital)
At the time of discharge or transfer to another hospital from the index hospital following cardiac arrest, and within 30 days
Difference between baseline and 72-hour creatinine
Periodo de tiempo: 72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and 72-hour creatinine
72 hours
Difference between baseline and the highest creatinine within 72 hours
Periodo de tiempo: 72 hours
Difference between baseline (the highest outpatient creatinine in the previous six months, or if unavailable, the creatinine on admission) and the highest creatinine within 72 hours
72 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Helsinki University Central Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de agosto de 2023

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STEPCARE-MAKE

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir