Peritoneal Dialysis as an Option of Unplanned Initiation of Chronic Dialysis (NCT02646436) | Clinical Trial Compass
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Peritoneal Dialysis as an Option of Unplanned Initiation of Chronic Dialysis
Brazil188 participantsStarted 2014-11-30
Plain-language summary
Peritoneal dialysis (PD) has become a well-established complementary alternative to haemodialysis (HD) as first-line renal replacement modality. At department of Botucatu Medical School, more than 60% of the chronic kidney disease (CKD) stage 5 patients are started urgently on chronic dialysis due to late referral or unexpected deterioration of residual renal function. These patients, although suitable for PD, were previously started on HD using central venous catheter. Since July 2014 patients have been offered urgent start on chronic PD right after PD-catheter insertion by percutaneous surgery, using Seldinger technique. The main objective is to compare technique and patients survival on unplanned PD vs. unplanned HD in the first 180 days. Methodology: Quasi experimental study which will describe how acute PD will initiated using high volume PD until metabolic and fluid control right after (\<48 h) PD catheter placement standard prescription for a 12 h overnight automatic PD until hospital discharge and intermittent PD at dialysis unit family training.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion criteria are CKD patients stage 5 (creatinine clearance \< 15 ml/min) requiring dialysis treatment immediately.
Exclusion Criteria:
* Presence of recent abdominal surgery (less than 30 days)
* Multiple previous abdominal surgery (more than two)
* Severe respiratory insufficiency (FiO2\> 70%)
* Abdominal infections
* Severe hyperkalemia with changes characteristic in EKG
* Acute pulmonary edema.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparasion of patients survival between unplanned PD vs. unplanned HD
Timeframe: 180 days
Trial details
NCT IDNCT02646436
SponsorUniversidade Estadual Paulista Júlio de Mesquita Filho