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

Peritonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621997
• Other study ID #: PD TRAINING
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: June 2018

Study information

• Verified date: July 2019
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritonitis

Intervention

Behavioral:
• operation inspection
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

Locations

Country	Name	City	State
China	Jie Dong	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first-episode peritonitis	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.	48 months
Secondary	first-episode enteric peritonitis,first-episode non-enteric peritonitis	Enteric organisms included enterococcus and enterobacter.	48 moths
Secondary	transition transition to haemodialysis, and all-cause death.	transition to haemodialysis, and all-cause death.	48 moths