Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion (TARGET UP)

King's College Hospital NHS Trust

Status: Enrolling

Conditions: Critically Ill

Treatments: Drug: 250 ML NaCl 4.5 MG/ML Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06158555

315717

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm

Experimental group

Description:

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

Treatment:

Drug: 250 ML NaCl 4.5 MG/ML Injection