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To evaluate the effect of an interventional approach vs a conventional approach in incident peritoneal dialysis patients

A randomised prospective open label comparative study: To evaluate the effect of an interventional approach (aimed at maintaining near pre dialytic ECW) vs a conventional approach (towards volume control) in incident peritonial dialysis patients on rate of decline of RRF and its association with the cardiovascular outcomes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/04/003561
Enrollment
80
Registered
2013-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Peritoneal Dialysis Patients

Interventions

Intervention1: Bioimpedance Analyser: Interventional Arm: In this arm fluid balance is maintaind based on the ECW values. Here the ECW (IG) is measured at every followup and the prescriptions will be

Sponsors

Baxter Evidence Council
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Stable incident CKD stage 4 patients 2. Must be willing to give consent

Exclusion criteria

Exclusion criteria: 1. Patient unwilling/unable to provide consent 2. Patient who are anuric or oliguric, at time of enrollment 3. Patient with life expectancy of less than 12 months 4. Pregnant or Lactating Women 5. Patient with history of likehood of poor compliance.

Design outcomes

Primary

MeasureTime frame
Prospective Analysis of the rate of decline of RRF between two groups of incident ESRD patients on PD; one the interventional group and the other conventional groupTimepoint: End of study—

Secondary

MeasureTime frame
Time to having of urine output in both groups Mean number of anti hypertensive medications in each grouopat the pre defined assessment interval Mean blood pressure in the two groups Change in CV profile of patints from baseline in each group as deduced by 2DEcho Outcomesintwogroups;definedascardiovasculareventsresultinginsymptoms/admissionofpatienttohospitalordeathThenumberofepisodesofdehydrationbetweengroupsNumberofemergencyhospitalizationsintwogroupsTimepoint: End of Study—

Countries

India

Contacts

Public ContactMrs Nagalakshmi AnandaPadmanabhan

Meenakshi Mission Hospital and Research Centre (MMHRC)

drksampath@gmail.com9994872250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026