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The Biological Rationale for Arginine vasopressin Versus Opinion (BRAVO) study: comparing effectiveness of two commonly used regimes of arginine vasopressin infusion when used with norepinephrine in treatment of hypotension.

A Pilot Pragmatic Study to assess the Effectiveness of two different AVP infusions regimes when used with Norepinephrine in hypotension: The BRAVO (Biological Rationale for AVP Versus Opinion) study

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000713493
Acronym
BRAVO
Enrollment
100
Registered
2025-07-07
Start date
2025-07-31
Completion date
2026-06-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a pilot pragmatic study to discover if starting Arginine Vasopressin (AVP) infusion at the same time as Norepinephrine (NE) infusion, and ceasing it after the NE is weaned reduces the number of hours on Vasopressors compared to starting the AVP after the NE dose reaches 0.2 mic/kg/min and stopping it when the NE is below that dose. Secondarily, are there less complications such as Continuous Renal Replacement Therapy (CRRT) requirement, less arrhythmias, less positive fluid balance, and less length of stay and death.

Interventions

Once shock, hypotension and a need for any pressor is recognised - start Arginine Vasopressin (AVP) at 0.04 U/min as a continuous intravenous infusion as soon as possible – ideally within 4 hours. If not already commenced intravenous infusion of norepinephrine (NE) can be added and titrated to Mean Arterial Pressure (MAP) of >65 mmHg or target MAP defined by clinician. The route is preferably through a central line, but as per local practice can be briefly administered through a proximal periphe

Once shock, hypotension and a need for any pressor is recognised - start Arginine Vasopressin (AVP) at 0.04 U/min as a continuous intravenous infusion as soon as possible – ideally within 4 hours. If not already commenced intravenous infusion of norepinephrine (NE) can be added and titrated to Mean Arterial Pressure (MAP) of >65 mmHg or target MAP defined by clinician. The route is preferably through a central line, but as per local practice can be briefly administered through a proximal peripheral line The clinician prescribing the infusions is the Emergency Medicine or Intensive Care doctor managing the patient. The clinician administering the medication is the Emergency or ICU nurse. The adherence to protocol will be assessed by the electronic medical record medication record that is recorded at every change of rate or dose and at least once an hour. If NE requirement is, or becomes, nil, continue AVP after cessation of NE, and review MAP and clinical perfusion markers. wean AVP in decrements of 0.01 U/min according to clinician preference.

Sponsors

Sunshine Coast University Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients Adults > 17 years old AND Clinicians want to start a vaso-pressor to maintain a prescribed Mean Arterial Pressure (MAP). AND Clinician wants an arterial line to monitor MAP (A diagnosis of sepsis or cardiogenic shock is not required, just that clinician requires a MAP and requires some pressor to achieve it – arterial access is mandatory, and central access is recommended, and mandatory after 12 hours if pressors still required. Initial use of proximal peripheral line acceptable. There is no requirement to have achieved a specific fluid load and all other interventions are up to the clinician).

Exclusion criteria

1. Clinician does not want to use AVP at any time 2. Acute mesenteric ischaemia recognised 3. Acute limb ischaemia recognised 4. Acute myocardial infact type 1 requiring intervention

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026