Renin-guided Hemodynamic Management in Patients With Shock

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage patients who are experiencing shock, a serious condition that can happen in critically ill patients and can be life-threatening. The researchers want to see if guiding treatment based on a specific hormone called renin can help improve patient outcomes, such as reducing the risk of death and kidney problems, compared to standard care. They will include 800 patients who need a medication called norepinephrine to keep their blood pressure stable and who are expected to stay in the intensive care unit (ICU) for at least 24 hours.

To participate in the trial, patients must be at least 18 years old, currently in the ICU, and require norepinephrine treatment. However, certain conditions like pregnancy, severe kidney issues, or recent involvement in another clinical trial will exclude them from participation. If eligible, patients will be randomly assigned to either the new treatment approach or the usual care, and they can expect close monitoring throughout the study to assess their health and recovery. This trial aims to provide more personalized and effective care for those facing the challenges of shock.

Gender

ALL

Eligibility 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