Critically IllTARGET UPNCT06158555
Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion
A study testing 250 ML NaCl 4.5 MG/ML Injection in people with Critically Ill, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
To assess the safety and feasibility of the IKORUS device in critically ill patients and to gather exploratory data on haemodynamic coherence Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- 250 ML NaCl 4.5 MG/ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Within 24 h of ICU admission
- Predicted length of ICU stay at least 5 days
- Receiving >0.1 mcg/kg/min of noradrenaline at time of study enrolment
Who cannot join
- Palliative treatment intent
- Contra indication to urethral catheterisation or complication during previous urethral catheter insertion
- Contraindication to fluid or vasopressor challenges in the opinion of the attending clinician
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Sam Hutchings, 02032994957, sam.hutchings@nhs.net
About this study
Official title: Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion - a Pilot Study
To assess the safety and feasibility of the IKORUS device in critically ill patients and to gather exploratory data on haemodynamic coherence
- Conditions
- Critically Ill
- Being tested
- 250 ML NaCl 4.5 MG/ML Injection
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 ML NaCl 4.5 MG/ML InjectionDrug
Bolus 250 ml crystalloid. Usually 0.9% saline or compound sodium lactate solution at discretion of attending clinician
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients will receive fluid and vasopressor challenges and the macro and microvascular responses will be recorded using the IKORUS monitor alongside conventional haemodynamic monitoring Receives: Drug: 250 ML NaCl 4.5 MG/ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change to Urethral Perfusion Index
Measured: 5 minutes after fluid challenge administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT06158555
- Sponsor's protocol ID
- 315717
- Acronym
- TARGET UP
- Status last verified
- Jan 2024
- First submitted
- 31 Aug 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion - a Pilot Study
- ClinicalTrials.gov ID
- NCT06158555
- Acronym / sponsor ID
- TARGET UP / 315717
- Conditions
- Critically Ill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
To assess the safety and feasibility of the IKORUS device in critically ill patients and to gather exploratory data on haemodynamic coherence
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: 250 ML NaCl 4.5 MG/ML InjectionPatients will receive fluid and vasopressor challenges and the macro and microvascular responses will be recorded using the IKORUS monitor alongside conventional haemodynamic monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Within 24 h of ICU admission
- Predicted length of ICU stay at least 5 days
- Receiving >0.1 mcg/kg/min of noradrenaline at time of study enrolment
Key exclusion criteria (3 listed)
- Palliative treatment intent
- Contra indication to urethral catheterisation or complication during previous urethral catheter insertion
- Contraindication to fluid or vasopressor challenges in the opinion of the attending clinician
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 |
|---|---|---|
| 250 ML NaCl 4.5 MG/ML InjectionBolus 250 ml crystalloid. Usually 0.9% saline or compound sodium lactate solution at discretion of attending clinician | Drug | Single Arm |
Primary outcome
Change to Urethral Perfusion Index
Time frame: 5 minutes after fluid challenge administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Critically Ill
Not yet recruitingObservational study
Lactate/Albumin Ratio and Mortality in Respiratory Failure
Acute Respiratory Failure, Critical Illness
RecruitingObservational study
Respiratory Physiotherapy and Inflammatory Biomarkers in Critically Ill Patients With Pneumonia
Pneumonia, Critical Illness
Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
RecruitingPhase 4
CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients
Severe Infection
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 250 ML NaCl 4.5 MG/ML Injection in people with Critically Ill, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Hutchings, PhD (020329994957, sam.hutchings@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change to Urethral Perfusion Index (time frame: 5 minutes after fluid challenge administration). 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 5 Jan 2024.