The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock (REPERFUSE)

K

King's College Hospital NHS Trust

Status

Not yet enrolling

Conditions

Acute Kidney Injury
Septic Shock

Treatments

Drug: Vasopressin
Drug: Angiotensin II
Drug: Norepinephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT06234592
328797

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

45 participants in 3 patient groups

Angiotensin II Infusion
Experimental group
Description:
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.
Treatment:
Drug: Norepinephrine
Drug: Angiotensin II
Vasopressin Infusion
Experimental group
Description:
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.
Treatment:
Drug: Norepinephrine
Drug: Vasopressin
Norepinephrine Infusion
Active Comparator group
Description:
Standard care vasopressor therapy which recruited participants already receiving, titrated to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.
Treatment:
Drug: Norepinephrine

Trial contacts and locations

1

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Central trial contact

Sam Hutchings

Data sourced from clinicaltrials.gov

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