The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2026-07-31

Brief Summary

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Acute kidney injury (AKI) is a common complication of septic shock and together these conditions carry a high mortality risk. In septic patients who develop severe AKI renal cortical perfusion is deficient despite normal macrovascular organ blood flow. This intra-renal perfusion abnormality may be amenable to pharmacological manipulation, which may offer mechanistic insight into the pathophysiology of septic AKI. The aim of the current study is to investigate the effects of vasopressin and angiotensin II on renal microcirculatory perfusion in a cohort of patients with septic shock.

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Detailed Description

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Conditions

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Septic Shock Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Angiotensin II Infusion

Angiotensin II infusion commenced alongside standard care vasopressor therapy (norepinephrine). Angiotensin II up titrated in a protocolised manner to a target/maximum dose of 40 ng/kg/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.

Group Type EXPERIMENTAL

Angiotensin II

Intervention Type DRUG

Angiotensin II infusion

Norepinephrine

Intervention Type DRUG

Standard care vasopressor therapy, norepinephrine infusion

Vasopressin Infusion

Vasopressin infusion commenced alongside standard care vasopressor therapy (norepinephrine). Vasopressin up titrated in a protocolised manner to a target/maximum dose of 0.04 IU/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.

Group Type EXPERIMENTAL

Vasopressin

Intervention Type DRUG

Vasopressin infusion

Norepinephrine

Intervention Type DRUG

Standard care vasopressor therapy, norepinephrine infusion

Norepinephrine Infusion

Standard care vasopressor therapy which recruited participants already receiving, titrated to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

Standard care vasopressor therapy, norepinephrine infusion

Interventions

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Angiotensin II

Angiotensin II infusion

Intervention Type DRUG

Vasopressin

Vasopressin infusion

Intervention Type DRUG

Norepinephrine

Standard care vasopressor therapy, norepinephrine infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Within 48 hours of intensive care admission
* Evidence of suspected or confirmed infection
* Sequential Organ Failure (SOFA) score increase of 2 or more (assuming a baseline of 0 if no previous measures)
* Requirement for norepinephrine infusion as the sole vasopressor agent in a dose of \>0.1mcg/kg/min
* Lactate \>2mmol/L at any stage prior to randomisation

Exclusion Criteria

* Known intolerance to Sonovue™ contrast medium, vasopressin or angiotensin II
* Patients receiving other vasoactive drugs in addition to norepinephrine
* Patients with known chronic kidney disease (CKD) stage 4 or 5 (baseline glomerular filtration rate (GFR) \<30mls/min)
* Patients receiving extra corporal membrane oxygenation (ECMO)
* Patients with acute occlusive coronary syndromes requiring intervention
* Patients with mesenteric ischaemia
* Patients with a history or presence of aortic dissection or abdominal aortic aneurysm
* Patients with Raynaud's syndrome or acute vaso-occlusive conditions
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No