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

Not Applicable

Recruiting

• Conditions: Critically Ill
• Interventions: Drug: 250 ML NaCl 4.5 MG/ML Injection

• Registration Number: NCT06158555
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	250 ML NaCl 4.5 MG/ML Injection	Patients will receive fluid and vasopressor challenges and the macro and microvascular responses will be recorded using the IKORUS monitor alongside conventional haemodynamic monitoring

Primary Outcome Measures

Name	Time	Method
Change to Urethral Perfusion Index	5 minutes after fluid challenge administration

Trial Locations

Locations (1)

King's College Hospital; 🇬🇧 London, United Kingdom