Renal Perfusion and the Development of AKI Following Traumatic Injury (PERTAKI)

April 1, 2025 updated by: King's College Hospital NHS Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to critical care with traumatic haemorrhagic shock who fulfill the inclusion and do no meet any exclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traumatic haemorrhagic shock
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at enrollment, +24 hours and + 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Contrast enhanced ultrasound measures of renal cortical tissue blood flow
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
Mean urinary pO2
Across 48 hour study period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at enrollment, +24 hours and + 48 hours
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
Measured at enrollment, +24 hours and + 48 hours
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
Measured at enrollment and + 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Estimated)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 334289

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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