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NCT Number: NCT06234592

The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock

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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Key information

Conditions

Septic Shock Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital

London, SE5 9RS, United Kingdom

Location status: Recruiting

Location contact

Sam Hutchings

CONTACT

[email protected]

02032994957

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin II

Drug

Angiotensin II infusion

Vasopressin

Drug

Vasopressin infusion

norepinephrine

Drug

Standard care vasopressor therapy, norepinephrine infusion

Primary outcomes

  1. Cortical mean transit time (mTT) measured in seconds

    Time frame: Measured at +24 hours following study vasopressor infusion starting

    Contrast enhanced ultrasound measure of renal cortical tissue blood flow

Secondary outcomes

  1. Cortical mean transit time (mTT) measured in seconds

    Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting

    Contrast enhanced ultrasound measures of renal cortical tissue blood flow

  2. Cortical perfusion index (PI) measured in arbitrary units

    Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting

    Contrast enhanced ultrasound measures of renal cortical tissue blood flow

  3. Cortical wash in rate (WiR) measured in arbitrary units

    Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting

    Contrast enhanced ultrasound measures of renal cortical tissue blood flow

  4. Urinary oxygen tension (pO2) across 24 hours study period measured in millimetres of mercury (mmHg)

    Time frame: Across 24 hours study period

    Mean urinary pO2

  5. 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

    Biomarker analysis - regulatory proteins involved in initiating cell cycle arrest and associated with AKI

Other outcomes

  1. Perfused vessel density (PVD) measured in millimetres per square millimetre

    Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting

    Incident dark field video microscopy measures of the systemic microcirculation

  2. Microvascular flow index (MFI) (unitless score from 0 to 3 where 3 is the value see in health).

    Time frame: Measured at +1 hour and +24 hours following study vasopressor infusion starting

    Incident dark field video microscopy measures of the systemic microcirculation

  3. Syndecan 1, angiopoietin 1 & 2, Interleukin 6 & 8 (IL-6, IL-8) and tissue necrosis factor (TNF). All measured in nanograms per millilitre (ng/ml)

    Time frame: Measured at baseline and +24 hours following study vasopressor infusion starting

    Biomarker analysis - markers of inflammation and endothelial activation/function

Study contacts

Contact information is provided by the study sponsor or research team.

Sam Hutchings

CONTACT

[email protected]

02032994957

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Collaborators

  • European Society of Intensive Care Medicine
  • Royal Centre for Defence Medicine

Registry information

Official study title

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

Acronym: REPERFUSE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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