None listed
Conditions
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.
Interventions
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
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.
Sponsors
Kidney, Transplant and Diabetes Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult (18 years of age or older) patients undergoing living donor kidney transplantation, who are able to provide written consent.
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.
Outcome results
None listed