Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07338435
NA

"Residual Kidney Function and Oxidative Stress in Incremental vs Standard Peritoneal Dialysis (2 Mexican Centers)"

Sponsor: Instituto Mexicano del Seguro Social

View on ClinicalTrials.gov

Summary

Title: Comparison of Oxidative Stress and Preservation of Residual Kidney Function Between Incremental and Standard Peritoneal Dialysis in Incident Patients at the Regional General Hospital No. 58 and HGZ/UMF 21 of the Mexican Institute of Social Security (IMSS) in León, Guanajuato BACKGROUND: Peritoneal dialysis (PD) employs hypertonic dextrose-based solutions to remove toxins and excess fluids. This exposure promotes mitochondrial overproduction of reactive oxygen species (ROS), triggers inflammation, and may accelerate the decline of residual kidney function (RKF), leading to complications such as peritonitis, peritoneal fibrosis, and technique failure. Although more biocompatible solutions are available, their high cost and limited accessibility restrict their use in our setting. Incremental peritoneal dialysis (IPD), in contrast to standard peritoneal dialysis (SPD)-which typically involves four daily exchanges with full-dose dialysis-uses reduced dialysis doses tailored to RKF, thereby decreasing glucose exposure. The primary aim of this study was to compare the effects of IPD versus SPD on oxidative stress, inflammation, and the preservation of residual kidney function in incident peritoneal dialysis patients at the Regional General Hospital No. 58 in León, Guanajuato. MATERIALS AND METHODS: A prospective, longitudinal, single-center, open-label, randomized clinical trial will be conducted. Incident peritoneal dialysis patients at the Regional General Hospital No. 58 and Gneral Hospital of Zone Numbre 21 of the Mexican Institute of Social Security (IMSS) who meet the inclusion criteria and provide informed consent will be randomly assigned to either the standard or incremental peritoneal dialysis group. Acute-phase reactants will be measured at baseline and at 3, 6, 9, and 12 months. Oxidative stress will be assessed via baseline and end-of-study malondialdehyde levels. Dialysis and urine Kt/V will be evaluated betwen 6 weeks and 3 moths and 6, 9, and 12 months. Appropriate statistical analyses will be performed thereafter.

Official title: "Comparison of Preservation Residual Renal Function and Oxidative Damage Between Incremental and Standard Peritoneal Dialysis in Incident Patients at Two Centers of Mexico.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-11-01

Completion Date

2026-07-01

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

PROCEDURE

Standard Peritoneal Dialysis

4 exchanges with nocturnal dwell.

PROCEDURE

Incremental Peritonal Dialysis

lower dialysis doses based on RKF, generally 3 exchanges or less.

Locations (1)

Instituto Mexicano del Seguro Social

León, Guanajuato, Mexico