Active not recruitingNAINTERVENTIONAL

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

This study is looking into how a patient's care right after a sudden heart attack affects their kidneys. Specifically, it's comparing different approaches to keeping patients calm (sedation), managing their body temperature, and controlling their blood pressure. The main goal is to see if any of these care methods can reduce the chance of serious kidney problems, such as acute kidney failure or needing dialysis. It's part of a larger study, and scientists are carefully looking at information from 3,500 patients to understand the best ways to protect kidney health during recovery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Helsinki University Central Hospital

Enrolment target

3,500

Start

17 Aug 2023

Estimated completion

01 Dec 2026

Acute Kidney Failure Renal Replacement Therapy for Acute Kidney Injury in ICU Sedation in Intensive Care Unit Patients Sedation in the ICU Sedation in Intensive Care Blood Pressure Mean Arterial Pressure Targets Temperature Fever Resuscitated Sudden Cardiac Death Out of Hospital Cardiac Arrest Cardiac Arrest (CA)

What is this study about?

Imagine someone has a sudden heart attack, and their heart stops beating outside the hospital. Thanks to quick action, their heart starts again, but they are still very unwell. This study is trying to find the best ways to care for these patients in the intensive care unit (ICU) to help them recover as fully as possible, especially focusing on protecting their kidneys.

Researchers are comparing three key aspects of care: how much medication is used to keep patients calm and asleep (sedation), how their body temperature is managed if they develop a fever, and what their blood pressure targets are. There are different approaches for each of these. For example, some patients might receive more sedation, while others get just enough to keep them comfortable. Similarly, doctors might use different ways to control temperature and hit different blood pressure goals.

The main aim is to see if any of these specific ways of caring for patients can prevent serious kidney problems. Kidney problems can include the kidneys not working properly, needing dialysis, or long-term damage. By carefully looking at information from many patients, the study hopes to find out which care strategies are most effective at keeping kidneys healthy during their recovery.

Key takeaways

The study explores how care after a heart attack impacts kidney health.
It compares different ways of managing sedation, body temperature, and blood pressure.
The goal is to find methods that reduce the risk of kidney problems.
All treatments being studied are current medical practices.
Data from 3,500 patients are being analyzed to improve future patient care.

Who may be eligible?

This study is for adults who had a sudden heart attack outside the hospital and whose heart started beating again. They must still be unconscious or need help breathing and be cared for in intensive care.

To be included, patients need to have had their heart start beating again for at least 20 minutes without needing chest compressions. They must also be able to receive full intensive care, and the decision to include them in the study needs to happen within 4 hours of their heart starting again.

Patients would not be able to join if their heart attack was due to a serious injury or bleeding, if they have bleeding in the brain, are pregnant, or if they needed a special heart-lung machine (ECMO) before joining the study.

Quick self-check

Did you have a sudden heart attack outside the hospital?
Did your heart start beating again (without needing chest massage for at least 20 minutes)?
Are you currently unconscious or needing help breathing?
Were doctors able to consider you for the study within 4 hours of your heart restarting?
Are you an adult (18 years or older)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are part of this study, it means that the doctors and nurses will be following a specific plan for your care after a heart attack. This plan will involve one of three pairs of strategies related to your sedation levels (how calm you are kept), how your body temperature is managed, and what your blood pressure target is. These decisions are made by the medical team as part of the study, and you or your family wouldn't need to do anything extra.

The medical team will carefully collect information about your health throughout your stay in the hospital, especially how your kidneys are working. This involves routine blood tests and monitoring that you would likely receive anyway as part of critical care. There are no additional visits or medications beyond the standard care provided in the ICU, just a focus on different standard treatment approaches. The overall duration of your involvement lasts throughout your hospital stay.

Potential risks and benefits

Being part of this study means your care after a heart attack will follow one of several established medical approaches for sedation, temperature, and blood pressure. The potential benefit is that by carefully comparing these approaches, doctors might learn which methods are best for protecting kidney health during recovery from a heart attack. This could help future patients. Because all the treatments being compared are current medical practices, there are no extra risks beyond what is already involved in intensive care after a heart attack. You, or your family once you are able, always have the right to withdraw from the study at any time, which would mean your care would no longer follow the specific study protocols, but would continue as standard medical care.

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

+40 more sites — see the official record for the full list.

Common questions

What is a 'heart attack' in this study?

In this study, 'heart attack' refers specifically to a sudden cardiac arrest where your heart stops beating completely outside of the hospital.

What does 'sedation' mean in this study?

Sedation means giving you medication to make you calm, relaxed, or asleep, which is often needed when you're on a breathing machine in intensive care.

Why are kidneys important for this study?

After a heart attack, the kidneys can sometimes be affected. This study wants to find the best ways to care for patients to help prevent kidney problems.

Will I get different medicines if I'm in the study?

The study looks at different ways to use existing medicines and treatments for sedation, temperature control, and blood pressure, not new or experimental drugs.

Who is paying for this research?

This information is not provided in the summary, but clinical trials are typically funded by research grants, government bodies, or pharmaceutical companies.