THE BRAZILIAN RANDOMIZED CONTROLLED UNBLINDED PILOT TRIAL OF URGENT START PERITONEAL DIALYSIS – THE BRUTUS TRIAL INITIAL RESULTS

 
THE BRAZILIAN RANDOMIZED CONTROLLED UNBLINDED PILOT TRIAL OF URGENT START PERITONEAL DIALYSIS – THE BRUTUS TRIAL INITIAL RESULTS
Helena
Balbé
Aryane Bastos-Bueno bastosaryane18@gmail.com Pro-rim Foundation Peritoneal Dialysis Joinville
Amanda Luz amandamluz@gmail.com Pro-rim Foundation Medical residency Joinville
Mariany Miyamoto marihimiya@gmail.com School of Medicine UNIVILLE Joinville
Helen Ferreira helen.ferreira@ctdr.com.br Pro-rim Foundation Peritoneal Dialysis Joinville
Andressa Zamprogna andressazamp@icloud.com Hans Dieter Schimidt Regional Hospital Medical residency Joinville
Gabriela Sevignani gabisevignani@gmail.com Pro-rim Foundation Peritoneal Dialysis Joinville
Viviane Calice-Silva viviane.silva@prorim.org.br Pro-rim Foundation Research Department Joinville
 
 
 
 
 
 
 
 

Urgent start peritoneal dialysis (US-PD) has been proposed as a modality for kidney replacement therapy (KRT) for those patients which did not receive pre-dialysis care and with no permanent access to dialysis. It has shown to be a feasible, safe, and efficient modality of KRT initiation. Thereby, evaluating the impact of both urgent start PD modalities: automated peritoneal dialysis (APD) and continuous ambulatorial peritoneal dialysis (CAPD) with low fill volume and standard volume (2 L/cycle) to the patients' clinical, metabolic and volemic control and outcomes could help to establish strategies to treat patients adequately according to the country's economic scenario. This could optimize PD to be used as a feasible KRT in an urgent manner, reducing the burden of end-stage kidney disease (ESKD) to the communities and health care systems worldwide. In this abstract we aimed to present a descriptive analysis of patients ‘characteristics, admission laboratory results, PD initiation indication, catheter implantation technique applied, first PD prescription used, and complications identified in the first dialysis session as well as quality-of-life and symptoms scores before start PD.  

This is a non-inferiority pilot single-center randomized control trial, unblinded, with the following specifications: 1) study cohort definition: adult ESKD patients with no permanent access to dialysis with the need of urgent dialysis initiation. 2) Urgent start PD definition: initiation of PD up to 3 days of catheter placement and some urgent indication for KRT. 3) Exclusion criteria: <18 years old, acute kidney injury patients, patients unable to give their informed consent to participate; patients with absolute contra-indications to PD. Patients were randomized in 3 groups as follows: group 1: standard volume APD (2L fill volume since the beginning, 5-8 exchanges per session), group 2: Low-volume APD (1-1,2L initial fill volume up to 2 L in 4 weeks, 5-8 exchanges per session) and group 3: low- volume CAPD (1-1,2L initial fill volume up to 2L in 4 weeks, 4-5 exchanges per session). Patients after hospital discharged were maintained on intermittent PD (3-4 times per week) at the dialysis unit until finalize the training to start at home. The adequate statistical analyses were performed with the software SPSS v27. 

So far, we have included 26 ESKD patients starting PD urgently that agreed to participating on the study, 9 in the group 1 and 2 and 8 in the group 3 according to the randomization process. Mean age was 55.9 ±17 years old, 61.5% were male, 80.8% self-reported as white race, most patients hypertensive and less diabetic. Mean eGFR was 8.22 (± 2.3) ml/min at PD initiation. Most patients started dialysis due to worsening in kidney function and uremic symptoms (77%). The mean time prescribed at the first dialysis session was 621.2 min (± 48.8). Median fill volume was 1,200 ml (IQR =875) and median total volume of 7,100 ml (IQR=4,500 ml). Median number of cycles was 6 (IQR=1). Most patients have the catheter placed by the Seldinger (percutaneous) technique (80.8%). No difference was found between groups in terms of race, gender, catheter technique implantation as well as laboratory results at admission. Only 2 patients have presented leakage at the first PD treatment, and both were from group 03 (CAPD low volume). No difference was found also in quality-of-life scores and symptoms parameters evaluated. The most common symptom identified was fatige (80%). No patient has dropped-out of therapy until the present. 

 

Patients ’clinical and demographic characteristics, admission laboratory results as well as PD initiation indication and quality-of-life and symptoms score were similar between groups. Only 2 patients in the CAPD low-volume group presented leakage at the first PD session. The most common implantation technique applied was the percutaneous one. No patients has dropped-out from the study until the present.

 

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