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

Not Applicable

Completed

• Conditions: Peritonitis
• Interventions: Behavioral: operation inspection

• Registration Number: NCT01621997
• Lead Sponsor: Peking University First Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2019-07
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
operation inspection	operation inspection	During retraining the patients performed bag exchange under the supervision of a nurse. The nurse ensured that each error listed in the NAC form should be avoided, thus immediately corrected any wrong steps if only.
verbal education	operation inspection	Patients in the oral education group also underwent retraining every 2 months. A nurse would address all items in the NAC form one by one, to remind the patient of the key points of bag exchange. Scores calculated by the sum of error items during the bag exchange for patients in technique inspection group, or by the sum of "yes" in the interactive quiz for patients in verbal education group.
usual care	operation inspection	Patients in the usual care group did not receive any retraining

Primary Outcome Measures

Name	Time	Method
first-episode peritonitis	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 Outcome Measures

Name	Time	Method
first-episode enteric peritonitis,first-episode non-enteric peritonitis	48 moths	Enteric organisms included enterococcus and enterobacter.
transition transition to haemodialysis, and all-cause death.	48 moths	transition to haemodialysis, and all-cause death.

Trial Locations

Locations (1)

Jie Dong; 🇨🇳 Beijing, Beijing, China