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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedation, temperature device and high MAP | Active Comparator | 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 |
|
| Sedation, no temperature device and high MAP | Active Comparator | Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥85mmHg |
|
| Sedation, temperature device and low MAP | Active Comparator | 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 |
|
| Sedation, no temperature device and low MAP | Active Comparator | Continuous deep sedation for 36 hours, fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback-controlled temperature device | Device | If core body temperature exceeds 37.7°C a feedback-controlled device will be used and set at 37.5°C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse kidney event (MAKE) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between baseline and the highest in-hospital creatinine | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital | Brisbane | Australia | ||||
| The Prince Charles Hospital |
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Participants will be blinded. Assessors of neurological prognosis will be blinded. Outcome assessors and investigators will be blinded. Health-care personnel will not be blinded.
| Minimal sedation, temperature device and high MAP |
| Active Comparator |
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 |
|
| Minimal sedation, no temperature device and high MAP | Active Comparator | Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg |
|
| Minimal sedation, temperature device and low MAP | Active Comparator | 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 |
|
| Minimal sedation, no temperature device and low MAP | Active Comparator | Minimal sedation (and early extubation if possible), fever management without a feedback-controlled device and a mean arterial pressure target of ≥65mmHg |
|
| High MAP | Other | A MAP target of >85mmHg will be used. Vasopressors will be titrated to this target during 36h |
|
| Deep sedation | Other | Deep sedation for at least 36h |
|
| Fever control without a device | Other | Management of fever in the ICU without a device |
|
| Low MAP | Other | A MAP target of >65mmHg will be used. Vasopressors will be titrated to this target during 36h |
|
| Minimal sedation | Other | A strategy of minimal sedation in the ICU, sedation used only as needed to facilitate transport, imaging and invasive procedures |
|
| Difference between baseline and the last measured in-hospital creatinine | 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 | 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 | 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 |
| 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 | 00290 | 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 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D005334 | Fever |
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054810 | Deep Sedation |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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