Effect of protein supplement in patients with peritoneal dialysis-related peritonitis on complicated outcome

Phase 3

Recruiting

• Conditions: Hypoalbuminemia in peritoneal dialysis-related peritonitis; Protein supplement; Peritoneal dialysis; Peritonitis; Hypoalbuminemia

• Registration Number: TCTR20210329002
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-29
• Study Completion: 2022-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

1. Adult ESKD patients with PD-related peritonitis
2. Hypoalbuminemia (serum albumin < 3.5 mg/dl)

Exclusion Criteria

- Patients requiring parenteral nutrition
- Patients with relapsing, repeated or recurrent PD-related peritonitis
- Patients with PD-related peritonitis due to fungus, mycobacteria, or secondary peritonitis
- Septic patients requiring vasopressor therapy
- Critically-ill or terminally-ill patients (including those with bedridden status)
- End-stage liver disease (Child-Pugh-Turcott classification B or C)
- Active cancer
- Pregnant women
- Known allergy to whey protein

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome of peritonitis-related death, relapsing peritonitis, and repeated peritonitis 3 months after completion of intervention Time to PD-related death, relapsing peritonitis or repeated peritonitis

Secondary Outcome Measures

Name	Time	Method
Serum albumin change from baseline 0, 1, 2, 3 months after completion of intervention Serum albumin change,Body weight change 0, 1, 2, 3 months after completion of intervention Body weight change