Renin-guided hemodynamic management: If normalization of renin levels is achieved (values within the normal laboratory range), we will continue with usual care according to local protocols.
Usual care: Standard of care
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
A composite of mortality or AKI progression at 30 days after randomization. — 30 days The primary outcome will be a composite of mortality or AKI progression at 30 days after randomization. We will define AKI progression as increasing at least two AKI stages compared to the AKI stage at study enrollment. We will define and stage AKI according to the current international criteria, the KDIGO guidelines (16). We will use both creatinine and urine output criteria.
Trial sites (3)
Facility
City
Region
Status
University Hospital Dubrava
Dubrava
Croatia
Recruiting
Ospedale Mater Domini
Catanzaro
Calabria
Not Yet Recruiting
IRCCS Ospedale San Raffaele
Milan
Italy
Recruiting
More Università Vita-Salute San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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