Trial Review

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Trial registered on ANZCTR


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] 307843 0
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 327484 0
renal replacement therapy 327485 0
Condition category
Condition code
Renal and Urogenital 324607 324607 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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] 324333 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332427 0
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] 332427 0
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] 413455 0
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] 413455 0
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] 413867 0
Cramping - as self-reported by participants to the clinician supervising the dialysis session
Timepoint [2] 413867 0
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] 413868 0
Dizziness or “Going flat”self-reported by participants to the clinician supervising the dialysis session
Timepoint [3] 413868 0
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] 413869 0
Gastrointestinal symptoms, including abdominal pain, nausea, and/or vomiting elf-reported by participants to the clinician supervising the dialysis session
Timepoint [4] 413869 0
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] 413870 0
Haemodynamic interventions (defined as fluid bolus and/or 10% increase in vasopressor) based on review of medical records
Timepoint [5] 413870 0
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] 413871 0
Session termination based on review of medical records
Timepoint [6] 413871 0
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
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
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] 23048 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 38378 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 312118 0
Hospital
Name [1] 312118 0
Austin Health
Country [1] 312118 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 313664 0
None
Name [1] 313664 0
Address [1] 313664 0
Country [1] 313664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311518 0
Austin Health
Ethics committee address [1] 311518 0
145 Studley Road, Heidelberg, Victoria, 3084
Ethics committee country [1] 311518 0
Australia
Date submitted for ethics approval [1] 311518 0
06/04/2022
Approval date [1] 311518 0
09/05/2022
Ethics approval number [1] 311518 0
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121382 0
Dr Chau (Joey) Lam
Address 121382 0
Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084
Country 121382 0
Australia
Phone 121382 0
+61 468612425
Fax 121382 0
Email 121382 0
joey.lam@austin.org.au
Contact person for public queries
Name 121383 0
Dr Chau (Joey) Lam
Address 121383 0
Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084
Country 121383 0
Australia
Phone 121383 0
+61 468612425
Fax 121383 0
Email 121383 0
joey.lam@austin.org.au
Contact person for scientific queries
Name 121384 0
Dr Chau (Joey) Lam
Address 121384 0
Austin Health, 145 Studley Road, Heidelberg, Victoria, 3084
Country 121384 0
Australia
Phone 121384 0
+61 468612425
Fax 121384 0
Email 121384 0
joey.lam@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
1. Patient demographics
2. Presence of chronic co-morbidities
3. Routine and event dialysis observations including subjective (e.g. cramping) and objective measures (e.g. non invasive blood pressure, blood volume)
4. Minutely haemodynamic parameters, as measured by ClearSight
When will data be available (start and end dates)?
immediately after publication and no end date
Available to whom?
case-by-case basis at the discretion of primary sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
The data can be obtained by contacting principal investigator (Dr Joey Lam, joey.lam@austin.org.au)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.