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Recruiting NCT06234592

The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock

No phase Interventional Septic Shock Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Angiotensin II, Vasopressin, Norepinephrine.
Who it may be relevant to
Registry conditions: Septic Shock, Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Vasopressor Therapy on Renal Perfusion in Patients With Septic Shock - a Mechanistically Focussed Randomized Control Study

Overview

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.

Interventions

  • Drug Angiotensin II
    Angiotensin II infusion
  • Drug Vasopressin
    Vasopressin infusion
  • Drug Norepinephrine
    Standard care vasopressor therapy, norepinephrine infusion

Primary outcome measures

  • Cortical mean transit time (mTT) measured in seconds [Time frame: Measured at +24 hours following study vasopressor infusion starting]
Secondary outcome measures (5)
  • Cortical mean transit time (mTT) measured in seconds [Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting]
  • Cortical perfusion index (PI) measured in arbitrary units [Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting]
  • Cortical wash in rate (WiR) measured in arbitrary units [Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting]
  • Urinary oxygen tension (pO2) across 24 hours study period measured in millimetres of mercury (mmHg) [Time frame: Across 24 hours study period]
  • Tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7). Both measured in nanograms per millilitre (ng/ml) [Time frame: Measured at baseline and +24 hours following study vasopressor infusion starting]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • King's College Hospital — London

Publications

  • McDonald R, Watchorn J, Mehta R, Ostermann M, Hutchings S. The REPERFUSE study protocol: The effects of vasopressor therapy on renal perfusion in patients with septic shock-A mechanistically focused randomised control trial. PLoS One. 2024 Jun 13;19(6):e0304227. doi: 10.1371/journal.pone.0304227. eCollection 2024. PMID 38870103

Identifiers

NCT: NCT06234592 · 328797

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗