An International, Multi-centre, Randomised Controlled Trial Co-designed With Consumers With Lived Experience of Peritoneal Dialysis (PD) to Determine the Optimal Approach to Starting Patients With Kidney Failure on PD
Overview
- Phase
- Not Applicable
- Intervention
- Incremental PD
- Conditions
- Peritoneal Dialysis (PD)
- Sponsor
- The University of Queensland
- Enrollment
- 224
- Locations
- 6
- Primary Endpoint
- Quality of Life (QoL)
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
Kidney failure is fatal without dialysis. Peritoneal dialysis (PD) completed at home offers greater flexibility and autonomy for patients . However, PD is often prescribed for 24 hours/day, 7 days/week for every patient starting dialysis. This practice is not evidence-informed, may be unnecessary and potentially harmful. The STEP-PD trial aims to determine the optimal approach to commencing patients on PD through starting at low dose PD and incrementing over time.
Detailed Description
The STEP-PD study is an investigator-initiated, pragmatic, international, multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial led by an international multi-disciplinary team of clinician scientists, nephrologists, consumers, social scientists, trialists, health economists, dialysis nurses, statisticians, and registry experts. The STEP-PD trial is co-designed with consumers with lived experience of peritoneal dialysis (PD) to determine the optimal approach to starting patients with kidney failure on PD. Specifically, this trial will test the hypothesis that, compared with full dose PD, starting patients on incremental start PD preserves symptom burden related quality of life (QOL), reduces dialysis burden, is safe, is more environmentally sustainable and costs less for patients, the community and the healthcare system. The STEP-PD trial has the potential to transform and personalise the treatment of kidney failure globally by providing definitive evidence on the patient-prioritised question regarding the effectiveness and safety of incremental start PD, particularly in relation to the patient-critical outcome of symptom burden-related QOL. Favourable results would lead to a paradigm shift in how patients are started on PD, thereby mitigating unnecessarily burdensome, expensive, and possibly harmful treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for \<1 month)
- •able to give informed consent
Exclusion Criteria
- •urine output \<0.5L/day
- •previous kidney transplant
- •unlikely to be on dialysis for ≥1 year.
- •known or planned pregnancy during the trial
Arms & Interventions
Incremental PD
Incremental PD: Commence PD using goal-directed PD prescription ≤14 exchanges/week for continuous ambulatory PD (CAPD) or ≤21 exchanges/week for automated PD (APD) with no day dwell until an indication for increase in the PD dose (trigger point) is reached.
Intervention: Incremental PD
Full dose PD
Full dose PD: Commence with 24 hours, 7 days/week PD (i.e., CAPD ≥28 exchanges/week or APD (overnight) with day dwell (i.e., no dry abdomen)).
Intervention: Full dose PD
Outcomes
Primary Outcomes
Quality of Life (QoL)
Time Frame: From enrollment to the end of treatment at 6 months
Symptom burden-related QOL 6 months after dialysis start, assessed by the Symptoms and Problems of Kidney Disease (SPKD) component of KDQOL-36 (0 to 100; worst to best).
Secondary Outcomes
- Death(Enrollment to 18 months)
- Major cardiovascular event(Enrollment to 18 months)
- Peritonitis(Enrollment to 18 months)
- Non-elective hospitalisations(Enrollment to 18 months)
- Hospitalisations(Enrollment to 18 months)
- Quality of Life (QOL) and life participation(Enrollment to 18 months)
- Serious adverse event(Enrollment to 18 months)
- Residual Kidney Function (RKF)(From enrollment to 3, 6, 9, 12 and 18 months)
- Anuria(From enrollment to 3, 6, 9, 12 and 18 months)