Traumatic Haemorrhagic ShockPERTAKINCT06917053
Renal Perfusion and the Development of AKI Following Traumatic Injury
An observational study of Traumatic Haemorrhagic Shock and AKI (Acute Kidney Injury) Due to Trauma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Haemorrhagic Shock, AKI (Acute Kidney Injury) Due to Trauma, AKI - Acute Kidney Injury
- What is being tested?
- Ultrasound (including contrast enhanced ultrasound), Sublingual incident dark field videomicroscopy and Urinary oxygen tension.
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2024to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to critical care with traumatic haemorrhagic shock who fulfill the inclusion and do no meet any exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Sam Hutchings, +442032994957, sam.hutchings@nhs.net
About this study
Official title: 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.
- Conditions
- Traumatic Haemorrhagic Shock, AKI (Acute Kidney Injury) Due to Trauma, AKI - Acute Kidney Injury
- Being tested
- Ultrasound (including contrast enhanced ultrasound), Sublingual incident dark field videomicroscopy, Urinary oxygen tension.
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound (including contrast enhanced ultrasound)Device
Ultrasound measures: contrast enhanced ultrasound (CEUS) of the kidney, venous excess ultrasound (VExUS), echocardiography
Sublingual incident dark field videomicroscopyDevice
Sublingual incident dark field (IDF) videomicroscopy
Urinary oxygen tension.Device
Continuous urinary oxygen tension
| Study group | Role | What they receive |
|---|---|---|
| Traumatic haemorrhagic shock | Not described Receives: Device: Ultrasound (including contrast enhanced ultrasound); Device: Sublingual incident dark field videomicroscopy; Device: Urinary oxygen tension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical mean transit time (mTT) measured in seconds
Contrast enhanced ultrasound measure of renal cortical tissue blood flow
Measured: Measured at enrollment, +24 hours and + 48 hours
Secondary outcomes (3)
Cortical perfusion index (PI) measured in arbitrary units
Contrast enhanced ultrasound measures of renal cortical tissue blood flow
Measured: 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
Measured: 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
Measured: Across 48 hour study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start13 Apr 2024
- Primary completionJan 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Haemorrhagic ShockStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917053
- Sponsor's protocol ID
- 334289
- Acronym
- PERTAKI
- Status last verified
- Mar 2025
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Perfusion and the Development of AKI Following Traumatic Injury - A Longitudinal Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06917053
- Acronym / sponsor ID
- PERTAKI / 334289
- Conditions
- Traumatic Haemorrhagic Shock, AKI (Acute Kidney Injury) Due to Trauma, AKI - Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 13 Apr 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic haemorrhagic shock | – | Device: Ultrasound (including contrast enhanced ultrasound), Device: Sublingual incident dark field videomicroscopy, Device: Urinary oxygen tension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to critical care with traumatic haemorrhagic shock who fulfill the inclusion and do no meet any exclusion criteria.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound (including contrast enhanced ultrasound)Ultrasound measures: contrast enhanced ultrasound (CEUS) of the kidney, venous excess ultrasound (VExUS), echocardiography | Device | Traumatic haemorrhagic shock |
| Sublingual incident dark field videomicroscopySublingual incident dark field (IDF) videomicroscopy | Device | Traumatic haemorrhagic shock |
| Urinary oxygen tension.Continuous urinary oxygen tension | Device | Traumatic haemorrhagic shock |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Haemorrhagic Shock and AKI (Acute Kidney Injury) Due to Trauma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sam Hutchings (+442032994957, sam.hutchings@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical mean transit time (mTT) measured in seconds (time frame: Measured at enrollment, +24 hours and + 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.