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RecruitingNCT06158555TARGET UPUpdated Jan 5, 2024

Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion

An interventional study of 250 ML NaCl 4.5 MG/ML Injection in Critically Ill, sponsored by King's College Hospital NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by King's College Hospital NHS Trust · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Apr 2023, registered Aug 2023).
  • Started Apr 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

To assess the safety and feasibility of the IKORUS device in critically ill patients and to gather exploratory data on haemodynamic coherence

02

Conditions studied

  • Critically Ill

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

King's College Hospital NHS Trust is the lead sponsor of 164 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Single Arm

    Patients will receive fluid and vasopressor challenges and the macro and microvascular responses will be recorded using the IKORUS monitor alongside conventional haemodynamic monitoring

    Drug: 250 ML NaCl 4.5 MG/ML Injection

Interventions

  • Drug250 ML NaCl 4.5 MG/ML Injection

    Bolus 250 ml crystalloid. Usually 0.9% saline or compound sodium lactate solution at discretion of attending clinician

06

What researchers measure

Primary outcomes

  1. Change to Urethral Perfusion Index

    Time frame: 5 minutes after fluid challenge administration

07

Study locations

1 of 1 sites recruiting
  • King's College Hospital
    London, SE5 9RS, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06158555
Lead sponsor
King's College Hospital NHS Trust
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Apr 1, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Jan 5, 2024

Study contacts

Sam Hutchings, PhD
Contact
sam.hutchings@nhs.net
020329994957

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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