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.

Abstract

Introduction: 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.

Methods and analysis: In this single centre, mechanistically focussed, randomised controlled study, 45 patients with septic shock will be randomly allocated to either of the study vasopressors (vasopressin or angiotensin II) or standard therapy (norepinephrine). Infusions will be titrated to maintain a mean arterial pressure (MAP) target set by the attending clinician. Renal microcirculatory assessment will be performed for the cortex and medulla using contrast-enhanced ultrasound (CEUS) and urinary oxygen tension (pO2), respectively. Renal macrovascular flow will be assessed via renal artery ultrasound. Measurement of systemic macrovascular flow will be performed through transthoracic echocardiography (TTE) and microvascular flow via sublingual incident dark field (IDF) video microscopy. Measures will be taken at baseline, +1 and +24hrs following infusion of the study drug commencing. Blood and urine samples will also be collected at the measurement time points. Longitudinal data will be compared between groups and over time.

Discussion: Vasopressors are integral to the management of patients with septic shock. This study aims to further understanding of the relationship between this therapy, renal perfusion and the development of AKI. In addition, using CEUS and urinary pO2, we hope to build a more complete picture of renal perfusion in septic shock by interrogation of the constituent parts of the kidney. Results will be published in peer-reviewed journals and presented at academic meetings.

Trial registration: The REPERFUSE study was registered on Clinical Trials.gov (NCT06234592) on the 30th Jan 24.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Acute Kidney Injury* / drug therapy
  • Acute Kidney Injury* / etiology
  • Adult
  • Angiotensin II / administration & dosage
  • Female
  • Humans
  • Kidney / blood supply
  • Kidney / drug effects
  • Kidney / physiopathology
  • Male
  • Microcirculation* / drug effects
  • Middle Aged
  • Norepinephrine / administration & dosage
  • Norepinephrine / therapeutic use
  • Renal Circulation / drug effects
  • Shock, Septic* / drug therapy
  • Shock, Septic* / physiopathology
  • Vasoconstrictor Agents* / administration & dosage
  • Vasoconstrictor Agents* / therapeutic use
  • Vasopressins / administration & dosage
  • Vasopressins / therapeutic use

Substances

  • Angiotensin II
  • Norepinephrine
  • Vasoconstrictor Agents
  • Vasopressins

Associated data

  • ClinicalTrials.gov/NCT06234592

Grants and funding

The study is jointly funded by the Medical Directorate of the Defence Medical Services (part of the UK Ministry of Defence) and the European Society of Intensive Care Medicine (ESICM). RMcD received both funding awards. The study is sponsored by King’s College Hospital NHS Foundation Trust. The study sponsor and funders played no role in the study design, data collection, analysis, decision to publish or manuscript preparation.