NCT06158555

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

August 31, 2023

Last Update Submit

January 3, 2024

Conditions

Critically Ill

Outcome Measures

Primary Outcomes (1)

  • Change to Urethral Perfusion Index

    5 minutes after fluid challenge administration

Study Arms (1)

Single Arm

EXPERIMENTAL

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

250 ML NaCl 4.5 MG/ML InjectionDRUG

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

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Injections

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Sam Hutchings, PhD

CONTACT

020329994957sam.hutchings@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

December 6, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)