Renin-guided Hemodynamic Management in Patients With Shock (NCT05898126) | Clinical Trial Compass
RecruitingNot Applicable
Renin-guided Hemodynamic Management in Patients With Shock
Croatia, Italy800 participantsStarted 2025-01-27
Plain-language summary
Shock is a major risk factor for mortality among patients admitted to intensive care units (ICUs). Since various hemodynamic strategies uniformly delivered to patients with shock have failed to improve clinically relevant outcomes, individualized approaches for shock supported by robust evidence are required. This study will be a prospective, multicenter, parallel-group, single-blind, randomized controlled trial. The investigators will randomly assign 800 critically ill patients requiring norepinephrine infusion to the renin-guided or usual care groups. The investigators hypothesize that renin-guided hemodynamic management, compared to usual care, can reduce a composite of mortality and acute kidney injury (AKI) progression in patients requiring vasopressor support.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 years old
* Admitted to an intensive care unit (ICU)
* Requiring norepinephrine infusion at any dose to maintain a mean arterial pressure (MAP) of ≥65 mmHg after initial fluid resuscitation
* Expected to stay in the ICU for at least 24 hours
* Written informed consent from the patient him-/herself or the patient's next of kin as requested by the ethics committee.
Exclusion Criteria:
* Pregnancy
* Refused informed consent
* Current enrollment into another randomized controlled trial that does not allow concomitant enrollment
* Requiring vasopressors for \>12 hours before the enrollment
* Renal failure with an imminent need for renal replacement therapy (RRT)
* Intention to use RRT by clinical judgment despite lack of urgent clinical indication
* AKI stage 2 and 3 at enrollment according to the KDIGO criteria
* Prior enrollment in this study
* Severe liver disease (Child-Pugh score \>7 points)
* Chronic kidney disease (CKD) equal to or worse than CKD stage IV (eGFR \<30 mL/min/1.73 m2)
* History of kidney transplant
* Any condition explicitly requiring a higher or lower blood pressure target according to clinical judgment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A composite of mortality or AKI progression at 30 days after randomization.