STarting incrEmental Prescription of Peritoneal Dialysis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Incremental PD, Full dose PD.
- Кому может быть актуально
- Состояния в реестре: Peritoneal Dialysis (PD), Kidney Failure. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австралия, Новая Зеландия, South Korea, Тайвань, Таиланд
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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. - Другое 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)).
Первичные конечные точки
- Quality of Life (QoL) [Срок оценки: From enrollment to the end of treatment at 6 months]
Вторичные конечные точки (9)
- Residual Kidney Function (RKF) [Срок оценки: From enrollment to 3, 6, 9, 12 and 18 months]
- Anuria [Срок оценки: From enrollment to 3, 6, 9, 12 and 18 months]
- Serious adverse event [Срок оценки: Enrollment to 18 months]
- Death [Срок оценки: Enrollment to 18 months]
- Major cardiovascular event [Срок оценки: Enrollment to 18 months]
- Peritonitis [Срок оценки: Enrollment to 18 months]
- Non-elective hospitalisations [Срок оценки: Enrollment to 18 months]
- Hospitalisations [Срок оценки: Enrollment to 18 months]
- Quality of Life (QOL) and life participation [Срок оценки: Enrollment to 18 months]
Критерии участия
Критерии включения
- adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for <1 month)
- able to give informed consent
Критерии исключения
- urine output <0.5L/day
- previous kidney transplant
- unlikely to be on dialysis for ≥1 year.
- known or planned pregnancy during the trial
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Австралия · 3 центра
- Blacktown — Blacktown
- Princess Alexandra Hospital — Brisbane
- Eastern Health — Box Hill
South Korea · 2 центра
- Hallym University Sacred Heart Hospital — Chuncheon
- Kyungpook National University — Daegu
Таиланд · 2 центра
- Banphaeo General Hospital — Ban Phaeo
- King Chulalongkorn Memorial Hospital — Bangkok
Новая Зеландия · 1 центр
- Waitemata — Auckland
Тайвань · 1 центр
- Taichung Veterans General Hospital — Taichung
Идентификаторы
NCT: NCT06642597 · AKTN 24.01