Chronic Kidney Disease, Diabetic Kidney Disease, Hypertension, Hypertension With Renal Dysfunction, Peritoneal Dialysis (PD)
Conditions
Keywords
inflammation., chronic kidney disease., oxidative stress, malondialdehyde, residual kidney function, incremental peritoneal dialysis, peritoneal dialysis
Brief 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.
Detailed description
Eligible incident peritoneal dialysis (PD) patients from two IMSS hospitals in León, Guanajuato (HGR No. 58 and HGZ-MF No. 21) will be enrolled after confirmation of adequate Tenckhoff catheter placement and written informed consent. Baseline demographic and clinical data will be collected from medical records and physical examination, including age, sex, marital status, educational level, anthropometric parameters (weight, height, body mass index), and volume status assessed by physical examination using the Godet edema scale. Laboratory evaluations will be performed in blood and urine. Fasting venous blood samples will be obtained for complete blood count, serum chemistry, electrolytes, lipid profile, inflammatory markers (albumin, ferritin, C-reactive protein, D-dimer), and viral serology (HBV, HCV, HIV). Oxidative stress will be assessed in serum by measuring thiobarbituric acid-reactive substances (TBARS) as an index of malondialdehyde concentration using a standardized spectrophotometric method. Residual renal function will be assessed at baseline and during follow-up (45 days, and 3, 6, 9, and 12 months) by estimated glomerular filtration rate (CKD-EPI equation), 24-hour urine volume, and 24-hour creatinine clearance. Solute clearance adequacy (renal and peritoneal Kt/V) will be measured at 1.5-3 months, 6 months, and 12 months. Peritoneal membrane transport characteristics will be evaluated at month 3 using the Peritoneal Equilibration Test (PET). Participants will be randomized in a 1:1 ratio to Incremental Peritoneal Dialysis or Standard Peritoneal Dialysis using block randomization (blocks of four). Glucose exposure will be quantified based on dialysate glucose concentration and number of exchanges, expressed as bags per year. Catheter-related complications and infection-free catheter survival will be monitored throughout the 12-month follow-up. After completion of follow-up, patients will continue PD according to their treating nephrologist's prescription.
Interventions
PROCEDUREStandard Peritoneal Dialysis
4 exchanges with nocturnal dwell.
PROCEDUREIncremental Peritonal Dialysis
lower dialysis doses based on RKF, generally 3 exchanges or less.
Sponsors
Universidad de Guanajuato
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The researchers will assign the participants by lottery using a table of numbers to each of the incremental or standard dialysis treatments, forming groups A and B. To form the treatment groups, the options will be A: Incremental peritoneal dialysis (IPD) and B: Standard peritoneal dialysis (standard PD or CAPD). A probabilistic number will be determined using block randomization, so the group will be divided into 10 blocks of 4 patients each, assigning 2 to group A and 2 to group B.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
CKD adults starting on PD FKR ≥2 mL/min Urine Volumen ≥500 mL/24 hrs Type 2 Diabetes, Hypertension and unknown cause of CKD
Exclusion criteria
Self-reported smoking or active use of illicit drugs. Patients with liver disease. Patients with glomerulonephritis. Patients with a history of previous renal replacement therapy (hemodialysis or kidney transplant).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress Serum malondialdehyde (MDA) levels | Baseline and 12 months | Oxidative stress will be assessed by serum malondialdehyde (MDA) concentration measured as thiobarbituric acid-reactive substances (TBARS) using spectrophotometry at 532 nm. Results will be expressed in nmol/mL. |
| Residual kidney function | Baseline, 45 days, 3 months, 6 months, 9 months, and 12 months | Residual kidney function will be evaluated by estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation (mL/min/1.73 m²), 24-hour, 24-hour urine volume (liters), and 24-hour creatinine clearance (mL/min). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic inflammation: Inflammatory biomarkers | at 3, 6,9, and 12 moths | Systemic inflammation will be assessed by serum levels of C-reactive protein (CRP, mg/L), ferritin (ng/mL), albumin (g/dL), and D-dimer (ng/mL), measured using standardized laboratory methods. |
| Catheter-related outcomes | Up to 12 months | Catheter outcomes will be assessed by time to first catheter-related complication or infection, expressed as complication-free catheter survival. |
Countries
Mexico
Outcome results
None listed