ANZCTR - Registration

Registration number

ACTRN12623000711617

Ethics application status

Approved

Date submitted

29/08/2022

Date registered

4/07/2023

Date last updated

4/07/2023

Date data sharing statement initially provided

4/07/2023

Type of registration

Retrospectively registered

Titles & IDs

Public title

Utility of Non-invasive Cardiac Output Estimation in Patients Undergoing Continuous Renal Replacement Therapy and Haemodialysis

Scientific title

Utility of Non-invasive Cardiac Output Estimation in Patients Undergoing Continuous Renal Replacement Therapy and Haemodialysis

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

NICO-PUNCH Feasibility Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

kidney disease

renal replacement therapy

Condition category

Condition code

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Observational

Description of intervention(s) / exposure

Participants: participants will undergo intermittent haemodialysis (IHD) or continuous renal replacement therapy (CRRT) as per usual prescribed by nephrologist or intensivist. The additional requirement that participants undergo as part of the study is to allow for an inflatable cuff to be placed over the middle phalanx of either hand of the 2nd, 3rd or 4th finger. They will be also asked of their experiences with the device being applied during time on haemodialysis. The on patient will only undergo monitoring during a single dialysis session.
Monitoring: use of the device and monitoring is continuous. Patients will be monitored with device on up to 30 minutes before and after their IHD or CRRT

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

This study is looking at the tolerability of using the non invasive cardiac output monitoring device (i.e. ClearSight) in addition to usual monitoring and intermittent haemodialysis (IHD) or continuous renal replacement therapy (CRRT). The patients' tolerability of the device will be assessed by using a semi structured interview with a member of the research team. The amount of time with device tolerated by patient as a proportion of total time of dialysis session will also be used as a measure of tolerability of the device; having the device on for more than. 90% of the total treatment session will be considered tolerable.

Timepoint [1]

The Clearsight device is applied to the patients up to 30minutes before their IHD or CRRT and then will continue to monitor until 30minutes after the session has finished. Each participant will only be assessed once for the entirety of the study and the monitoring is continuous

Secondary outcome [1]

Intradialytic hypotension (defined as SBP <90mmHg and/or decrease of more than or equal to 20mmHg) as measured by the non invasive blood pressure measure from the IHD and CRRT machines as well as from the Clearsight device

Timepoint [1]

The Clearsight device is applied to the patients up to 30minutes before their IHD or CRRT and then will continue to monitor until 30minutes after the session has finished. Each participant will only be assessed once for the entirety of the study and the monitoring is continuous.

Secondary outcome [2]

Cramping - as self-reported by participants to the clinician supervising the dialysis session

Timepoint [2]

The Clearsight device is applied to the patients up to 30minutes before their IHD or CRRT and then will continue to monitor until 30minutes after the session has finished. Each participant will only be assessed once for the entirety of the study and the monitoring is continuous. The patients will be asked periodically if they have this complaint.

Secondary outcome [3]

Dizziness or “Going flat”self-reported by participants to the clinician supervising the dialysis session

Timepoint [3]

The Clearsight device is applied to the patients up to 30minutes before their IHD or CRRT and then will continue to monitor until 30minutes after the session has finished. Each participant will only be assessed once for the entirety of the study and the monitoring is continuous. The patients will be asked periodically if they have this complaint.

Secondary outcome [4]

Gastrointestinal symptoms, including abdominal pain, nausea, and/or vomiting elf-reported by participants to the clinician supervising the dialysis session

Timepoint [4]

The Clearsight device is applied to the patients up to 30minutes before their IHD or CRRT and then will continue to monitor until 30minutes after the session has finished. Each participant will only be assessed once for the entirety of the study and the monitoring is continuous. The patients will be asked periodically if they have this complaint.

Secondary outcome [5]

Haemodynamic interventions (defined as fluid bolus and/or 10% increase in vasopressor) based on review of medical records

Timepoint [5]

The Clearsight device is applied to the patients up to 30minutes before their IHD or CRRT and then will continue to monitor until 30minutes after the session has finished. Each participant will only be assessed once for the entirety of the study and the monitoring is continuous.

Secondary outcome [6]

Session termination based on review of medical records

Timepoint [6]

The Clearsight device is applied to the patients up to 30minutes before their IHD or CRRT and then will continue to monitor until 30minutes after the session has finished. Each participant will only be assessed once for the entirety of the study and the monitoring is continuous. The patients will be asked periodically if they have this complaint.

Eligibility

Key inclusion criteria

Patients will be included if the following criteria are fulfilled:
o They are adult (patients are 18 years old or older )
o The patient is currently undergoing either CRRT or IHD
o Informed consent can be provided by the patient or medical treatment decision maker
o At least one arm without arteriovenous fistula and/or graft

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Consistent with the recommendations using the ClearSight system, Patients will only be excluded if they have a clinical history of severe peripheral vascular disease or Raynaud’s disease, intubated or unable to objectively report symptoms.

Study design

Statistical methods / analysis

Statistical analysis will be performed using computerized software (STATA SE/16.0, StataCorp, College Station, Texas, USA). Baseline characteristics will be reported as frequencies and percentages, means, standard deviation, or medians and interquartile ranges. Summary statistics will include t-test, chi squared test, and Wilcoxon rank sum test, as dictated by data type. Descriptive statistics will be used for the primary and secondary outcome analyses.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

26/08/2022

Date of last participant enrolment

Anticipated

31/07/2023

Actual

Date of last data collection

Anticipated

31/07/2023

Actual

Sample size

Target

30

Accrual to date

2

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

145 Studley Road, Heidelberg, Victoria, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/04/2022

Approval date [1]

09/05/2022

Ethics approval number [1]

HREC/85569/Austin-2022

Summary

Brief summary

To assess the clinical utility of using a non-invasive haemodynamic monitoring device (the Clearsight TM system) in the cardiac assessment of patients undergoing CRRT and IHD
To evaluate the feasibility of using the Clearsight TM system on patients that are currently on CRRT

To evaluate the feasibility of using the Clearsight TM system on patients that are currently on IHD

To evaluate the haemodynamic changes that occur during a CRRT session and how are these changes correlated to the clinical status of the patient

To evaluate the haemodynamic changes that occur during an IHD session and how are these changes correlated to the clinical status of the patient

Patients rercruited would have already been receiving IHD or CRRT and were then approached to enter this study. Patients would not have their IHD or CRRT intervention altered in anyway. The ClearSight cardiac output monitoring device is a small pressure cuff that is applied the the middle phalanx of either the 2nd, 3rd or 4th finger. This allows for continuous monitoring of cardiac output

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Chau (Joey) Lam

Address

Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 468612425

Email

[email protected]

Contact person for public queries

Name

Chau (Joey) Lam

Address

Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 468612425

Email

[email protected]

Contact person for scientific queries

Name

Chau (Joey) Lam

Address

Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084

Country

Australia

Phone

+61 468612425

Email

[email protected]

Trial Review

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Documents added automatically