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NCT Number: NCT06917053

Renal Perfusion and the Development of AKI Following Traumatic Injury

Acute kidney injury (AKI) is a complication of traumatic haemorrhagic shock (THS) and together these conditions increase mortality risk. Although septic shock patients who develop severe AKI are known to develop hypoperfusion of the renal cortex, little is known regarding intra-renal perfusion changes in THS. The aim of the current study is to investigate the effects of THS on renal microcirculatory perfusion.

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Key information

Conditions

Traumatic Haemorrhagic Shock AKI (Acute Kidney Injury) Due to Trauma AKI - Acute Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital

London, SE5 9RS, United Kingdom

Location status: Recruiting

Location contact

Sam Hutchings

CONTACT

[email protected]

+442032994957

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Within 24 hours of ICU admission following traumatic injury
  • Received any blood products during initial resuscitation
  • Lactate > 2 mmol/l at any stage prior to study enrolment

Exclusion criteria

  • Known intolerance to Sonovue or any other ultrasound contrast agent
  • Patients with un-survivable injuries / not expected to survive 24 hours in whom the intent of treatment is palliative
  • Known CKD 4 or end stage renal failure
  • Pregnancy

Treatment and study plan

Ultrasound (including contrast enhanced ultrasound)

Device

Ultrasound measures: contrast enhanced ultrasound (CEUS) of the kidney, venous excess ultrasound (VExUS), echocardiography

Sublingual incident dark field videomicroscopy

Device

Sublingual incident dark field (IDF) videomicroscopy

Urinary oxygen tension.

Device

Continuous urinary oxygen tension

Primary outcomes

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

    Time frame: Measured at enrollment, +24 hours and + 48 hours

    Contrast enhanced ultrasound measure of renal cortical tissue blood flow

Secondary outcomes

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

    Time frame: Measured at enrollment, +24 hours and + 48 hours

    Contrast enhanced ultrasound measures of renal cortical tissue blood flow

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

    Time frame: Measured at enrollment, +24 hours and + 48 hours

    Contrast enhanced ultrasound measures of renal cortical tissue blood flow

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

    Time frame: Across 48 hour study period

    Mean urinary pO2

Other outcomes

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

    Time frame: Measured at enrollment, +24 hours and + 48 hours

    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 enrollment, +24 hours and + 48 hours

    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 enrollment and + 48 hours

    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]

+442032994957

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

Renal Perfusion and the Development of AKI Following Traumatic Injury - A Longitudinal Observational Cohort Study

Acronym: PERTAKI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 8, 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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