Renin-guided Hemodynamic Management in Patients With Shock
NCT ID: NCT05898126
Last Updated: 2025-08-06
Study Results
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Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2025-01-27
2027-07-28
Brief Summary
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Detailed Description
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Recent studies have investigated renin as a novel marker of tissue hypoperfusion in critically ill patients. While serum lactate level has been the most common and validated marker for tissue hypoperfusion (12), several studies are now suggesting that renin may predict mortality better than lactate in critically ill patients (13, 14). Notably, relative renin increase is associated with adverse clinical outcomes and shock reversal has been shown to decrease renin concentration (15).
The investigators aim to perform the Randomized Evaluation of persoNalized hemodynamIc maNagement based on serum renin concentration (RENIN) trial to test the hypothesis that renin-guided hemodynamic management can reduce a composite of mortality and acute kidney injury (AKI) progression during the hospital stay in patients requiring vasopressors compared with usual care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Renin-guided hemodynamic management
We will measure serum renin values every six hours. If the measured renin concentration increases by more that 20% compared with the last value, the target mean arterial pressure (MAP) will be elevated to 75-80 mmHg. If the subsequent renin level is still rising, the target MAP will be further raised to 85-90 mmHg and the addition of inotropes will be considered. If the first subsequent renin level decreases or increases by ≤20%, the target MAP will be kept at 75-80 mmHg. If the renin level at the subsequent measurement after reaching the highest step of management protocol is still increasing, a failure of the intervention will be declared, the target MAP will return to 65-70 mmHg. If renin level further decreases or increases ≤20% for two consecutive measurements, we will downgrade the target MAP to the previous step.
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
Patients in the usual care group will be managed according to standard of practice at each participating center.
Usual care
Standard of care
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Università Vita-Salute San Raffaele
OTHER
Responsible Party
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Giovanni Landoni
MD, Full Professor
Locations
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University Hospital Dubrava
Dubrava, , Croatia
Ospedale Mater Domini
Catanzaro, Calabria, Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Nikola Bradic, MD
Role: primary
Andrea Bruni, MD
Role: primary
References
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Other Identifiers
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GR-2021-12375069
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RENIN - 141/INT/2022
Identifier Type: -
Identifier Source: org_study_id
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