NCT06917053

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Apr 2024Jul 2026

Study Start

First participant enrolled

April 13, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 8, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

April 1, 2025

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cortical mean transit time (mTT) measured in seconds

    Contrast enhanced ultrasound measure of renal cortical tissue blood flow

    Measured at enrollment, +24 hours and + 48 hours

Secondary Outcomes (3)

  • Cortical perfusion index (PI) measured in arbitrary units

    Measured at enrollment, +24 hours and + 48 hours

  • Cortical wash in rate (WiR) measured in arbitrary units

    Measured at enrollment, +24 hours and + 48 hours

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

    Across 48 hour study period

Other Outcomes (3)

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

    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)

    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)

    Measured at enrollment and + 48 hours

Study Arms (1)

Traumatic haemorrhagic shock

Device: Ultrasound (including contrast enhanced ultrasound)Device: Sublingual incident dark field videomicroscopyDevice: Urinary oxygen tension.

Interventions

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

Traumatic haemorrhagic shock

Sublingual incident dark field (IDF) videomicroscopy

Traumatic haemorrhagic shock

Continuous urinary oxygen tension

Traumatic haemorrhagic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma / serum / urine

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2025

First Posted

April 8, 2025

Study Start

April 13, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 8, 2025

Record last verified: 2025-03

Locations