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Recruiting NCT06917053

Renal Perfusion and the Development of AKI Following Traumatic Injury

— Observational Traumatic Haemorrhagic Shock AKI (Acute Kidney Injury) Due to Trauma AKI - 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: Ultrasound (including contrast enhanced ultrasound), Sublingual incident dark field videomicroscopy, Urinary oxygen tension..
Who it may be relevant to
Registry conditions: Traumatic Haemorrhagic Shock, AKI (Acute Kidney Injury) Due to Trauma, AKI - 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Ultrasound (including contrast enhanced ultrasound)
    Ultrasound measures: contrast enhanced ultrasound (CEUS) of the kidney, venous excess ultrasound (VExUS), echocardiography
  • Device Sublingual incident dark field videomicroscopy
    Sublingual incident dark field (IDF) videomicroscopy
  • Device Urinary oxygen tension.
    Continuous urinary oxygen tension

Primary outcome measures

  • Cortical mean transit time (mTT) measured in seconds [Time frame: Measured at enrollment, +24 hours and + 48 hours]
Secondary outcome measures (3)
  • Cortical perfusion index (PI) measured in arbitrary units [Time frame: Measured at enrollment, +24 hours and + 48 hours]
  • Cortical wash in rate (WiR) measured in arbitrary units [Time frame: Measured at enrollment, +24 hours and + 48 hours]
  • Urinary oxygen tension (pO2) across 24 hours study period measured in millimetres of mercury (mmHg) [Time frame: Across 48 hour study period]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

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

Identifiers

NCT: NCT06917053 · 334289

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗