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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-12-01

Brief Summary

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

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Detailed Description

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Conditions

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Critically Ill

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

250 ML NaCl 4.5 MG/ML Injection

Intervention Type DRUG

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

Interventions

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250 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No