CTRI Number |
CTRI/2019/05/019383 [Registered on: 27/05/2019] Trial Registered Prospectively |
Last Modified On: |
27/06/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
What happens to phosphorus levels during hemodialysis? |
Scientific Title of Study
|
Phosphate kinetics in Indian hemodialysis patients - an observational study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
None |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Namrata Rao S |
Designation |
Assistant Professor |
Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
Address |
Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
Phone |
09454360872 |
Fax |
|
Email |
snamratarao@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Namrata Rao S |
Designation |
Assistant Professor |
Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
Address |
Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
Phone |
09454360872 |
Fax |
|
Email |
snamratarao@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Namrata Rao S |
Designation |
Assistant Professor |
Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
Address |
Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow UTTAR PRADESH 226010 India |
Phone |
09454360872 |
Fax |
|
Email |
snamratarao@yahoo.co.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Dr Namrata Rao S |
Address |
Department of Nephrology, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Lucknow - 226010 |
Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Namrata Rao |
Dr. Ram Manohar Lohia Institute of Medical Sciences |
Hemodialysis unit, Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow Lucknow UTTAR PRADESH |
09454360872
snamratarao@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethical Committee, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patient of endstage renal disease on maintenance hemodialysis for > 3 months
No hospitalizations in the last 3 months
Written, informed consent
|
|
ExclusionCriteria |
Details |
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
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To prospectively evaluate phosphate removal by hemodialysis in patients with endstage renal disease in a tertiary care hospital in northern India |
0,1,2,3,4,5 hours after onset of dialysis |
|
Secondary Outcome
|
Outcome |
TimePoints |
None |
NA |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
28/05/2019 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
1. Reddy YNV, Sundaram V, Abraham G, et al. Optimal management of hyperphosphatemiain end-stage renal disease: an Indian perspective. Int J Nephrol Renovasc Dis. 2014; 7: 391-399.
2. Daugirdas JT. Removal of phosphorus by hemodialysis. Sem Dial. 2015; 28: 620-623.
3. Agar BU, Akonour A, Lo YC, et al. Kinetic model of phosphorus mobilization during and after short and conventional hemodialysis. Clin J Am Soc Nephrol. 2011; 6: 2854-2860.
4. Elias RM, Alvares VRC, Moyses RMA. Phosphate removal during conventional hemodialysis: a decades-old misconception. Kidney Blood Press Res. 2018; 43: 110-114.
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Hyperphosphatemia
in endstage renal disease patients has been associated with greater risk of
mortality, especially due to cardiovascular causes (1). Most commonly,
nephrologists employ an approach of dietary phosphorus restriction, use of
phosphate binders and hemodialysis, to facilitate maintenance of serum
phosphate levels in dialysis patients. A majority of Indian dialysis patients
receive two/week hemodialysis sessions, as against three/week in the Western
world. Indian diet is vastly different from typical Western diet and various
regional differences exist too. Dietary modifications to increase protein and minimize
phosphorus intake, are only variably successful, as cost and logistics play greater
role in deciding the patient’s diet, rather than the clinician’s advice (1).
Therefore, the onus of phosphate removal falls upon a combination of phosphate
binders and the hemodialysis sessions.
Brief
review: Regarding
dialytic phosphorus removal, available literature is unclear whether short,
frequent hemodialysis sessions are more beneficial than prolonged sessions in
reducing serum phosphorus levels (2,3). To our knowledge, only a single study has
evaluated dialytic phosphorus removal over a period of time (4). This study
found out that while the first hour of hemodialysis normalizes serum phosphorus
levels, significant amount of phosphorus continues to be removed in the
subsequent hours as well. The present study will observe dialysis phosphorus
removal at hourly intervals and help in deciding which approach will tackle hyperphosphatemia effectively – increasing dialysis duration or
frequency. Moreover, no other study has undertaken the evaluation of dietary
phosphorus intake and dialytic phosphorus removal in an Indian population
before. |