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OpenTrials
Completed

NCT Number: NCT01621997

Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis

To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jie Dong

Beijing, Beijing Municipality, 100034, China

About this study

The design is prospective, randomized, controlled study. At baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis.

Then the participants will be randomized into three groups: retraining via operation inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be performed every 2 months in G1 and G2 group.

During the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CAPD patients.
  • Medically stable and receiving PD for<1 week
  • age between 18 and 80 years
  • self-care or doing bag exchange by a fixed assistant Exclusion Criteria
  • followed up at least every 2 months
  • dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China

Exclusion criteria

  • Pregnancy;
  • undergoing APD therapy
  • Intolerance to the study protocols;
  • Severe and unstable condition, acute or chronic inflammation disease;
  • a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months;
  • suffering peritonitis before receiving the interventions
  • cognitive or psychological dysfunction;
  • communication barrier

Treatment and study plan

operation inspection

Behavioral

Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months.

Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months

Primary outcomes

  1. first-episode peritonitis

    Time frame: 48 months

    Infection rates were calculated as the number of infections divided by the total time at risk, and expressed as episodes per 100 patient-years at risk.

Secondary outcomes

  1. first-episode enteric peritonitis,first-episode non-enteric peritonitis

    Time frame: 48 moths

    Enteric organisms included enterococcus and enterobacter.

  2. transition transition to haemodialysis, and all-cause death.

    Time frame: 48 moths

    transition to haemodialysis, and all-cause death.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2012
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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