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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06158555
Other study ID # 315717
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date December 1, 2024

Study information

Verified date January 2024
Source King's College Hospital NHS Trust
Contact Sam Hutchings, PhD
Phone 020329994957
Email sam.hutchings@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
United Kingdom King's College Hospital London

Sponsors (1)

Lead Sponsor Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change to Urethral Perfusion Index 5 minutes after fluid challenge administration
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