ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001093774

Ethics application status

Approved

Date submitted

15/07/2022

Date registered

8/08/2022

Date last updated

24/11/2024

Date data sharing statement initially provided

8/08/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Personalised Post-operative monitoring and fluid therapy vs standard of care in recipients of Living donor kidney transplant

Scientific title

Pilot Randomised Controlled Trial of Personalised Goal Directed Therapy after Adult Living Donor Kidney Transplant.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1280-3038

Trial acronym

Linked study record

Health condition

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

Kidney failure

Kidney Transplantation

Condition category

Condition code

Renal and Urogenital

Kidney disease

Surgery

Other surgery

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

There is currently clinical equipose on management of recipients of kidney transplants postoperatively between high acuity or ward based environments.

Patients in the intervention arm will be admitted post operatively into the Advanced Recovery Room within the Royal Adelaide Hospital, for monitoring for 24 hours post operatively. The parameters that will be monitored will include a variety of haemodynamic measures, such as blood pressure, central venous pressure and mean arterial pressure. In addition, novel haemodynamic monitoring using the ClearSight™ and FloTrac™ devices (Edwards Lifescience™) will enable capture of, via the EV1000 Clinical Monitoring Platform, more advanced haemodynamic monitoring such as cardiac index and pulse pressure variation. Markers of end organ perfusion such as capillary refill time, urine output and serum haemoglobin and lactate will also be used in the multimodal haemodynamic assessment. Interpretation of the urine output trend, haemoglobin trend and lactate trend will rely on clinical judgement. A more detailed intervention protocol and assessment algorithm is available in Appendix 2 and 5 within the attached study protocol.
Arterial lines will be placed if clinically indicated, at the judgement of clinician

The entirety of the intervention will be delivered under the direct supervision of the personnel below.
Personnel involved in care will be
• Renal speciality nurse – rostered to 1:1 patient care as “nursing special” for 24 hours post transplantation
• Advanced Recovery nurse – will assist with haemodynamic monitoring and use of vasopressors
• Renal resident medical officer – on site 24 hours
• Advanced recovery RMO – will assist with clinical reviews
• Renal registrar – on call 24 hours
• Anaesthetist– on call 24 hours
• Transplant nephrologist - on call 24 hours
• Other consulting clinicians as required.

The proposed post-operative targets are as below
Systolic blood pressure > 100 - As per both Clearsight AND non-invasive blood pressure (BP)
MAP > 70 as per Clearsight device
Stroke Volume Variation < 13% as per Clearsight device
Haemoglobin trend acceptable, as interpreted by bedside clinician
Urine Output acceptable, as interpreted by bedside clinician
Lactate trend acceptable (If arterial line in situ) - as interpreted by bedside clinician
Capillary refill time less than 2 secs

Review of patient medical record will be undertaken to ensure adherence with study protocol.
At the end of the study period, participants will be managed on the kidney ward.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Patients in the control arm will receive current standard of care, as per the Central Adelaide Local Health Network Renal Transplant: Post-Operative Management protocol (CNARTS-PRC03932).
Personnel involved in care will be
• Renal speciality nurse – rostered to 1:1 patient care as “nursing special” for 24 hours post transplantation
• Renal resident medical officer – Basic Physician Trainee, employed by the Royal Adelaide Hospital, on site 24 hours.
• Renal registrar – Renal Advanced Trainee, employed by Central and Northern Adelaide Renal and Transplantation Service, on call 24 hours.
• Transplant nephrologist - employed by Central and Northern Adelaide Renal and Transplantation Service, on call 24 hours.
• Other consulting clinicians as required.

Control group

Active

Outcomes

Primary outcome [1]

Safety end point
Adverse event reporting – defined as harm resulted to a person receiving healthcare and stratified using the Severity Assessment Codes

Timepoint [1]

3 months post operatively

Primary outcome [2]

Feasibility end point - composite primary outcome of rate of enrolment into the study, measured against all living donor kidney transplant performed at the Royal Adelaide Hospital, and adherence to study protocol.

Rate of enrolment will be assessed via audit of study recruitment logs.
Adherence to study protocol can be measured objectively by real time data recording at the time of intervention as well as semi structured interviews (performed at 6 months) with renal nurses and ARRC staff

Timepoint [2]

At conclusion of study

Primary outcome [3]

Efficacy End point
Difference between average 24 hour mean arterial pressure – calculated by comparing the area under the curve of mean arterial pressure over time.
Measured at the same intervals in both groups. recorded via electronic medical record

Timepoint [3]

At conclusion of study

Secondary outcome [1]

Incidence of hypotension – recorded via electronic medical record

Timepoint [1]

48 Hours post operatively

Secondary outcome [2]

Duration of hypotension – Measured in 30-minute blocks. Recorded via electronic medical record

Timepoint [2]

48 hours post operatively

Secondary outcome [3]

Incidence of slow graft function – defined by ANZDATA definition. Recorded via electronic medical record

Timepoint [3]

48 hours post operatively

Secondary outcome [4]

Adverse graft outcomes – composite outcome of graft thrombosis, graft loss within 30 days, urine leak, urinary tract obstruction and rejection or wound complications requiring intervention.
Recorded via electronic medical record

Timepoint [4]

30 days post operatively

Secondary outcome [5]

Vasopressor use – defined by the amount of vasopressor use in the first 24-hour post operatively, measured in mg. Metaraminol with be the preferred vasopressor use.
Recorded via electronic medical record

Timepoint [5]

24 hours post operatively

Secondary outcome [6]

Urine output volume within the first 24 hours
Recorded via electronic medical record

Timepoint [6]

24 hours post operatively

Secondary outcome [7]

Length of stay – From elective admission to hospital until discharge from hospital
Recorded via electronic medical record

Timepoint [7]

30 days post operatively

Secondary outcome [8]

Number of ICU admissions – defined by admission to the intensive care unit within 48 hours post operatively
Recorded via electronic medical record

Timepoint [8]

48 hours post operatively

Eligibility

Key inclusion criteria

Adult (18 years of age or older) patients undergoing living donor kidney transplantation, who are able to provide written consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patient requiring peri-operative plasma exchange for either high Angiotensin II Receptor Type 1 antibodies or pre-formed Human Leukocyte Antigen (HLA) antibodies. These patients may require post operative plasma exchange, which may not be able to be delivered in a timely fashion to the intervention arm with current levels of resourcing.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocations will be concealed using the randomisation module in RedCap. An external statistician will generate the randomisation sequence and upload it to the RedCap module. The sequence will be locked and masked, and will not be accessible to the investigators.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation sequence will be generated externally by a statistical consultant using permuted block randomisation, with variable block sizes.
Participants will be stratified based on hypertension, defined as the use of one or more antihypertensive agents.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Frequencies, expressed as percentages, will be reported for categorical variables.
The measures of central tendencies will be calculated for continuous demographic data; reported as mean and standard deviations for normally distributed variables and median and interquartile range for non-normally distributed data.
The difference between groups will be assessed using either t test or Wilcoxon rank sum test for continuous variables and chi-squared test for categorical variables.
The primary efficacy end point, namely the difference in mean 24-hour blood pressure between the control and intervention groups will be compared using generalised estimating equations

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/02/2023

Actual

15/02/2024

Date of last participant enrolment

Anticipated

31/01/2024

Actual

15/04/2024

Date of last data collection

Anticipated

Actual

4/06/2024

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Royal Adelaide Hospital, Port Rd
Adelaide, South Australia 5000

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Kidney, Transplant and Diabetes Research Australia

Address

Level 1, 62 Woodville Road Woodville, SA 5011

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics

Ethics committee address [1]

Port Road
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/08/2022

Approval date [1]

27/12/2022

Ethics approval number [1]

2022/HRE00180

Summary

Brief summary

Chronic Kidney Disease affects 1 in 10 Australian adults, with almost 15,000 Australians relying on dialysis to survive. Kidney transplantation provides better quality of life and long-term survival, in addition to being more cost effective when compared to dialysis. However, transplantation requires major surgery, which is associated with a number of serious risks and adverse events. One such adverse event is hypotension, or low blood pressure, after the operation, which may starve the newly transplanted kidney of oxygen and nutrients in the critical post-transplant period. The effect of this low blood pressure on short, medium and long term kidney transplant function is unknown. The best way to prevent, monitor and treat low blood pressure during this period is also unknown.

The care of a new kidney transplant in the first 24 hours of the operation is very important. Parameters such as blood pressure, the amount of fluid delivered and the amount of urine produced make all have an impact on how well a new transplant kidney works in the immediate post operative period. Optimisation of these parameters may have an impact on long-term kidney transplant function. 
This is a pilot study looking at different way that patients can be monitored after kidney transplant. The study would aim to compare current protocols against additional methods of monitoring blood pressure and fluid status, to see if this leads to better outcomes. 

This study is a randomised trial. Participants will be randomised to 1 of 2 post operative care models. 

One model is the current standard Royal Adelaide Hospital post transplantation management protocol, which will involve being managed on the kidney ward with a team of kidney doctors and nurses after time spent in recovery. 

The second model will involve participants being admitted to a specialised advanced recovery area for 24 hours after kidney transplantation. Participants will have regular observations and occasional blood tests. The study may require the placement of an arterial line, which is a line that can be used for intensive blood pressure monitoring and blood taking without the need for additional venepuncture. After the operation, participants will be monitored carefully by a team consisting of kidney doctors, recovery nurses and kidney nurses trained in post-transplant care. After 24 hours, participants will move to the kidney ward.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Karthik Venkataraman

Address

Central and Northern Adelaide Renal and Transplantation Service, Level 7F
Royal Adelaide Hospital, Port Rd, Adelaide, SA, 5000

Country

Australia

Phone

+61430495079

Fax

karthik.venkataraman@sa.gov.au

Contact person for public queries

Name

Michael Collins

Address

Central and Northern Adelaide Renal and Transplantation Service, Level 7F
Royal Adelaide Hospital, Port Rd, Adelaide, SA, 5000

Country

Australia

Phone

+61474871437

Fax

michael.collins@sa.gov.au

Contact person for scientific queries

Name

Michael Collins

Address

Central and Northern Adelaide Renal and Transplantation Service, Level 7F
Royal Adelaide Hospital, Port Rd, Adelaide, SA, 5000

Country

Australia

Phone

+61474871437

Fax

michael.collins@sa.gov.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?

Individual participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.

When will data be available (start and end dates)?

Start date: Data will be available 12 months post main publication
End Date: 15 years (data destruction)

Available to whom?

Researchers who provide a methodologically sound proposal will be assessed on a case-by-case basis, and data will be released at the discretion of the principle

Available for what types of analyses?

Meta-analyses

How or where can data be obtained?

Access subject to approvals by Principal Investigator (karthik.venkataraman@sa.gov.au)

What supporting documents are/will be available?

Doc. No.	Type	Attachment
16618	Study protocol	384365-(Uploaded-14-07-2022-13-25-02)-Study-related document.docx
16619	Informed consent form	384365-(Uploaded-14-07-2022-13-25-33)-Study-related document.docx
18017	Ethical approval	384365-(Uploaded-09-01-2023-14-42-11)-Study-related document.pdf

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.

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