Personalized hemodynamic management for patients in shock
Official title: Effect of Personalized Hemodynamic Management Based on Serum Renin Concentration on Acute Kidney Injury Progression in Patients With Shock: a Randomized Controlled Trial.
Run by Università Vita-Salute San Raffaele · NCT05898126 · Data updated 2026-11-12
This study tests if managing blood flow based on hormone levels can help critically ill patients in shock do better and avoid serious kidney problems compared to standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 3 sites (Dubrava and 2 other locations) |
| Status | Recruiting |
| Started | January 27, 2025 |
| Main results expected | April 28, 2027 |
| Study ends | July 28, 2027 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT05898126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are critically ill patients aged 18 and older who require norepinephrine infusion to maintain adequate blood pressure.
✕Probably not a fit
Patients with severe renal failure requiring immediate renal replacement therapy or those with advanced chronic kidney disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of renin-guided hemodynamic management compared to usual care in critically ill patients experiencing shock. The study will randomly assign 800 patients requiring norepinephrine infusion to either the renin-guided group or the usual care group. The goal is to determine if personalized management based on renin levels can reduce mortality and the progression of acute kidney injury. The trial is designed as a multicenter, parallel-group, single-blind, randomized controlled trial.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality and acute kidney injury in patients with shock.
How similar studies have gone: Previous studies have shown that personalized hemodynamic strategies can improve outcomes, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital Dubrava
Dubrava, Croatia Recruiting -
IRCCS Ospedale San Raffaele
Milan, Italy Recruiting -
Ospedale Mater Domini
Catanzaro, Calabria, Italy Not yet recruiting
Study contacts
- Study coordinator: Alessandro Belletti, MD
- Email: belletti.alessandro@hsr.it
- Phone: 0039 0226436151
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.