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Clinical Trials/CTRI/2019/05/019383
CTRI/2019/05/019383Not yet recruitingNot Applicable

Phosphate kinetics in Indian hemodialysis patients - an observational study

Dr Namrata Rao S1 site in 1 country40 target enrollmentStarted: May 28, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To prospectively evaluate phosphate removal by hemodialysis in patients with endstage renal disease in a tertiary care hospital in northern India

Study Overview

Brief Summary

Hyperphosphatemiain endstage renal disease patients has been associated with greater risk ofmortality, especially due to cardiovascular causes (1). Most commonly,nephrologists employ an approach of dietary phosphorus restriction, use ofphosphate binders and hemodialysis, to facilitate maintenance of serumphosphate levels in dialysis patients. A majority of Indian dialysis patientsreceive two/week hemodialysis sessions, as against three/week in the Westernworld. Indian diet is vastly different from typical Western diet and variousregional differences exist too. Dietary modifications to increase protein and minimizephosphorus intake, are only variably successful, as cost and logistics play greaterrole in deciding the patient’s diet, rather than the clinician’s advice (1).Therefore, the onus of phosphate removal falls upon a combination of phosphatebinders and the hemodialysis sessions.

Briefreview: Regardingdialytic phosphorus removal, available literature is unclear whether short,frequent hemodialysis sessions are more beneficial than prolonged sessions inreducing serum phosphorus levels (2,3). To our knowledge, only a single study hasevaluated dialytic phosphorus removal over a period of time (4). This studyfound out that while the first hour of hemodialysis normalizes serum phosphoruslevels, significant amount of phosphorus continues to be removed in thesubsequent hours as well. The present study will observe dialysis phosphorusremoval at hourly intervals and help in deciding which approach will tackle hyperphosphatemia  effectively – increasing dialysis duration orfrequency. Moreover, no other study has undertaken the evaluation of dietaryphosphorus intake and dialytic phosphorus removal in an Indian populationbefore.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patient of endstage renal disease on maintenance hemodialysis for > 3 months No hospitalizations in the last 3 months Written, informed consent.

Exclusion Criteria

  • •Need for hospitalization in the last 3 months Inability to record diet and drug history Hemodialysis sessions requiring blood transfusion Missed session of hemodialysis in the preceding week.

Outcomes

Primary Outcomes

To prospectively evaluate phosphate removal by hemodialysis in patients with endstage renal disease in a tertiary care hospital in northern India

Time Frame: 0,1,2,3,4,5 hours after onset of dialysis

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Namrata Rao S
Sponsor Class
Government medical college

Study Sites (1)

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