Actively Recruiting
Renin-guided Hemodynamic Management in Patients With Shock
Led by Università Vita-Salute San Raffaele · Updated on 2025-08-06
800
Participants Needed
3
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Renin-guided Hemodynamic Management in Patients With Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Admitted to an intensive care unit (ICU)
- Requiring norepinephrine infusion at any dose to maintain mean arterial pressure of at least 65 mmHg after initial fluid resuscitation
- Expected to stay in the ICU for at least 24 hours
- Provided written informed consent from the patient or next of kin as required by ethics committee
You will not qualify if you...
- Pregnancy
- Refusal to provide informed consent
- Currently enrolled in another randomized controlled trial that does not allow combined participation
- Receiving vasopressors for more than 12 hours before enrollment
- Renal failure with imminent need for renal replacement therapy (RRT)
- Planned use of RRT despite no urgent clinical indication
- Acute kidney injury stage 2 or 3 at enrollment according to KDIGO criteria
- Previous enrollment in this study
- Severe liver disease with Child-Pugh score over 7 points
- Chronic kidney disease stage IV or worse (eGFR less than 30 mL/min/1.73 m2)
- History of kidney transplant
- Any condition requiring a different blood pressure target based on clinical judgment
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Hospital Dubrava
Dubrava, Croatia
Actively Recruiting
2
Ospedale Mater Domini
Catanzaro, Calabria, Italy
Not Yet Recruiting
3
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
A
Alessandro Belletti, MD
CONTACT
N
Nicola Buzzatti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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