Managing blood flow in critically ill patients using a new device
Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion - a Pilot Study
NA · King's College Hospital NHS Trust · NCT06158555
This study is testing a new device to see if it can help improve blood flow in critically ill patients who have just been admitted to the ICU and are on medication to support their blood pressure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT06158555 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of the IKORUS device for targeted perfusion management in critically ill patients. It aims to gather exploratory data on haemodynamic coherence by administering a specific saline injection. The study focuses on patients who are within 24 hours of ICU admission and are receiving noradrenaline. The intervention involves monitoring the effects of urethral perfusion on patient outcomes over a set period.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients admitted to the ICU within the last 24 hours who require vasopressor support.
Not a fit: Patients receiving palliative care or those with contraindications to urethral catheterization will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve hemodynamic stability and outcomes for critically ill patients.
How similar studies have performed: There is limited information on similar studies, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
London
- King's College Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Sam Hutchings, PhD
- Email: sam.hutchings@nhs.net
- Phone: 020329994957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Critically Ill