Renin-guided Hemodynamic Management in Patients With Shock
Recruiting now · Not applicable
Conditions studied: Shock
In brief
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.
Key facts
- Study ID
- NCT05898126
- Run by
- Università Vita-Salute San Raffaele
- People needed
- 800
- Starts
- 2025-01-27
- Expected to finish
- 2027-07-28
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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.
You may not qualify if…
- 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
Where it is running
- University Hospital Dubrava — Dubrava, Croatia (enrolling)
- IRCCS Ospedale San Raffaele — Milan, Italy (enrolling)
- Ospedale Mater Domini — Catanzaro, Calabria, Italy
Full record on ClinicalTrials.gov
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