Renal Perfusion and the Development of AKI Following Traumatic Injury

ConditionsTraumatic Haemorrhagic Shock AKI (Acute Kidney Injury) Due to Trauma AKI - Acute Kidney Injury

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKing's College Hospital NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Traumatic haemorrhagic shock3 interventions

Trial outcomes

Primary outcomes

Cortical mean transit time (mTT) measured in seconds

Contrast enhanced ultrasound measure of renal cortical tissue blood flow

Time frame

Measured at enrollment, +24 hours and + 48 hours

Secondary outcomes

Cortical perfusion index (PI) measured in arbitrary units

Contrast enhanced ultrasound measures of renal cortical tissue blood flow

Time frame

Measured at enrollment, +24 hours and + 48 hours

Cortical wash in rate (WiR) measured in arbitrary units

Contrast enhanced ultrasound measures of renal cortical tissue blood flow

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)

Mean urinary pO2

Time frame

Across 48 hour study period

Other outcomes

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

Incident dark field video microscopy measures of the systemic microcirculation

Time frame

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)

Incident dark field video microscopy measures of the systemic microcirculation

Time frame

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)

Biomarker analysis - markers of inflammation and endothelial activation/function

Time frame

Measured at enrollment and + 48 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College Hospital NHS Trust

Lead sponsor

Source ClinicalTrials.gov

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