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Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent Sepsis

ConditionSeptic Shock
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital do Coracao

About this trial

The norepinephrine and vasopressin for rescue versus early vasopressin for vasopressor dependent sepsis (NoVa) is a phase 3, multicenter, open-label, randomized controlled trial comparing an early vasopressin initiation strategy versus norepinephrine plus vasopressin initiation only as a rescue strategy for hemodynamic management of critically ill patients with vasopressor dependent sepsis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with vasopressor dependent sepsis, defined by infection suspicion and antibiotic administration or laboratory confirmed viral infection, plus hypotension with the need of vasopressors for at least one hour;

Admitted or expected to be admitted to the ICU in the next 12 hours

Adequate volume resuscitation in the opinion of the attending physician

Use of norepinephrine > 0.05μg/Kg/min and ≤ 0.25μg/Kg/min for at least 1 hour and at most 24 hours at the time of inclusion

Disqualifiers

Use of norepinephrine > 0.25μg/Kg/min in the last 24 hours, except when administered transiently in the context of sedation for a procedure or the initial phase of volume resuscitation for a period of less than one hour

Dialysis-dependent chronic kidney disease or acute kidney injury that received renal replacement therapy during current hospitalization or are expected to receive renal replacement therapy in the next 24 hours

Use of other vasopressors (except norepinephrine) at the moment of inclusion

Use of vasopressors for sepsis in the last 7 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Vasopressin

    Drug

    Early Vasopressin group: Vasopressin up to 0.04U/min initiated after randomization.

  • Norepinephrine and Vasopressin for Rescue

    Drug

    Norepinephrine and Vasopressin for Rescue group: Vasopressin up to 0.04U/min initiated only if norepinephrine dose exceeds 0.5 μg/kg/min.

Treatment groups

2,800 Participants
are divided into 2 treatment groups
Group A: Early VasopressinExperimental treatment 1 intervention
Group B: Norepinephrine plus vasopressin for rescueActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality or renal replacement therapy

Composite of all-cause mortality or renal replacement therapy within 28 days after randomization.

Time frame
28 days

Secondary outcomes

1

All-cause mortality

All-cause mortality within 28 days after randomization

Time frame
28 days
2

Renal replacement-therapy

Need of renal replacement therapy within 28 days after randomization.

Time frame
28 days
3

Renal replacement-free days

Renal-replacement free days are defined by the number of days a patient is alive and free of renal replacement support between randomization and day 28. Non-survivors will be considered to have zero renal replacement-free days.

Time frame
28 days
4

ICU-free days

Number of days a patient is alive and outside the ICU between randomization and day 28. Non-survivors will be considered to have zero ICU-free days.

Time frame
28 days

Other outcomes

Sponsors and contacts

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

Hospital do Coracao

Lead sponsor

Brazilian Research In Intensive Care Network

Collaborator

National Institute of Science and Technology (INCT) in Precision Intensive Care Medicine

Collaborator

Source ClinicalTrials.gov
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