Personalized hemodynamic management for patients in shock
Effect of Personalized Hemodynamic Management Based on Serum Renin Concentration on Acute Kidney Injury Progression in Patients With Shock: a Randomized Controlled Trial.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 3 sites (Dubrava and 2 other locations) |
| Trial ID | NCT05898126 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients aged 18 and older who require norepinephrine infusion to maintain adequate blood pressure.
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.
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 performed: Previous studies have shown that personalized hemodynamic strategies can improve outcomes, suggesting potential success for this novel approach.
Eligibility criteria
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 this trial is running
Dubrava and 2 other locations
- University Hospital Dubrava — Dubrava, Croatia (Recruiting)
- Ospedale Mater Domini — Catanzaro, Calabria, Italy (Not_yet_recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Belletti, MD
- Email: belletti.alessandro@hsr.it
- Phone: 0039 0226436151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.