RecruitingNot ApplicableNCT05898126

Renin-guided Hemodynamic Management in Patients With Shock

Effect of Personalized Hemodynamic Management Based on Serum Renin Concentration on Acute Kidney Injury Progression in Patients With Shock: a Randomized Controlled Trial.

Sponsor

Università Vita-Salute San Raffaele

Enrollment

800 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Shock

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

Min Age: 18 Years

Inclusion Criteria5

≥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 Criteria12

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

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Interventions

PROCEDURERenin-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.

PROCEDUREUsual care

Standard of care