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Renin-guided Hemodynamic Management in Patients With Shock

ConditionShock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità Vita-Salute San Raffaele

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Renin-guided hemodynamic management

    Procedure/Surgery

    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

    Procedure/Surgery

    Standard of care

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Renin-guided hemodynamic managementExperimental treatment 1 intervention
Group B: Usual careSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

A composite of mortality or AKI progression at 30 days after randomization.

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.

Time frame
30 days

Secondary outcomes

1

All-cause mortality at intensive care unit discharge, hospital discharge, and 90 days after randomization.

Time frame
90 days
2

The need for and duration of vasopressors at 30 days after randomization

Deaths within the initial 30 days were assigned 30 days of duration of vasopressors at day 30.

Time frame
30 days
3

Days alive and free from mechanical ventilation

Deaths within the initial 30 days were assigned zero days alive and free from mechanical ventilation at day 30.

Time frame
30 days
4

Day alive and free from renal replacement therapy.

Deaths within the initial 30 days were assigned zero days alive and free from renal replacement therapy at day 30.

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Università Vita-Salute San Raffaele

Lead sponsor

Source ClinicalTrials.gov
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