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Идёт набор NCT06065982

Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)

— Наблюдательное End-stage Kidney Disease

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: Questionnaires.
Кому может быть актуально
Состояния в реестре: End-stage Kidney Disease. 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
Бельгия, Нидерланды
Следующий шаг
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Официальное название

Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters

Обзор

Peritoneal dialysis (PD) is the most frequent modality of home dialysis for patients with kidney failure. Most PD catheters are placed using a laparoscopic technique. This approach requires the availability of a qualified surgeon, time in the operating theater and general anaesthesia for the patient. Thus, the laparoscopic technique is less suitable for patients with severe heart failure or multimorbidity where general anaesthesia is not possible. PD catheters can also be inserted using a percutaneous strategy using a modified Seldinger technique. This strategy can be performed bedside under local anaesthesia, by the nephrologist, radiologist, a surgeon, physician assistant or qualified nurse. The availability of the percutaneous implantation strategy of a PD catheter in a nephrology center may accomodate more patients to receive a PD catheter insertion, including those who have a contraindication to general anaesthesia or need urgent PD. The PREDICT project aims to increase knowledge and competencies on percutaneous PD catheter insertions by training centers for this technique. By establisching a prospective registry, the outcomes of percutaneously inserted PD catheters, both in experienced and newly trained centers, will be assessed.

Подробное описание

The population of the PREDICT study are adult patients requiring a peritoneal dialysis catheter insertion. Decision for percutaneous strategy of catheter insertion (versus surgical catheter insertion) is made by the treating physician.

The inclusion criteria for the prospective PREDICT registry are age \> 18 years and percutaneous PD catheter insertion between 1 March 2023 and 1 March 1 2026 in participating centers.

Patients can be included 4 weeks before until 12 weeks after PD catheter insertion. The exclusion criteria are the inability to give informed consent and a life expectancy of less than 3 months.

Demographic and clinical data will be collected for all included patients.

Вмешательства

  • Другое Questionnaires
    Health-related quality of life will be measured using the 12-item Short Form (SF-12) and EQ5D-5L questionnaires. The SF-12 is summarized into two component scores, the Physical Component Score (PCS) and Mental Composite Score (MCS).

Первичные конечные точки

  • Implementation of percutaneus PD catheter insertion technique in dialysis centers [Срок оценки: through study completion, 3 years]
  • Outcomes of percutaneous inserted PD catheters in participating centers [Срок оценки: Over 12 months after percutaneous insertion]
Вторичные конечные точки (9)
  • The presence of functioning PD catheter [Срок оценки: Over 3 and 6 months after percutaneous PD catheter insertion]
  • Insertion-related complications [Срок оценки: Perforation during or within 48 hours after catheter insertion, bleeding within 7 days of insertion, and PD-related infections within 30 days of insertion]
  • Mechanical complications [Срок оценки: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch]
  • The rate of PD utilization [Срок оценки: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch]
  • Health-related quality of life as assessed by the SF-12 questionnaire [Срок оценки: At baseline and at 12 months after percutaneous PD catheter insertion]
  • Self-assessed health-related quality of life using the EQ5D questionnaire. [Срок оценки: At baseline and at 12 months after percutaneous PD catheter insertion]
  • Health care professionals' perspective on the implementation process [Срок оценки: At baseline and yearly]
  • Evolution in HD/PD ratio in participating centers throughout the study period [Срок оценки: Through study completion, 3 years]
  • Costs of the procedure [Срок оценки: immediately after the intervention]

Критерии участия

Критерии включения

  • Age > 18 years
  • Percutaneous PD catheter insertion between March 1st 2023 and March 1st 2026 Patients can be included 4 weeks before until 12 weeks after PD catheter insertion

Критерии исключения

  • Inability to provide informed consent
  • Life expectancy < 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Бельгия · 1 центр
  • Universitair Ziekenhuis Brussel — Brussels
Нидерланды · 1 центр
  • UMC Utrecht — Utrecht

Идентификаторы

NCT: NCT06065982 · UZB-NEF-2023-PREDICT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗