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CTRI Number  CTRI/2019/05/019403 [Registered on: 29/05/2019] Trial Registered Prospectively
Last Modified On: 27/05/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Protein supplement powder]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Timing of eating during dialysis: its effects and side-effects 
Scientific Title of Study   Predialytic versus intradialytic nutrition: Tolerability and effects on solute removal during hemodialysis 
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  
Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
 
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  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
None  NA 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral administration of protein supplement powder at two hours after dialysis initiation  The same oral nutrition powder as before, will be administered after two hours of starting dialysis session, and the patients will undergo the same monitoring and testing as in the intervention group. As this is a crossover study, all patients shall serve as their own comparators.  
Intervention  Oral administration of protein supplement powder before the onset of dialysis  All the patients shall serve as their own comparators. The oral nutrition supplement shall contain 450 kcal energy, 20 g protein (in the form of milk and whey protein concentrates), phosphorus 170 mg, potassium 250 mg and 180 ml water. Patients dialysed in the morning shift shall receive the oral nutritional supplement one hour prior to the start of hemodialysis (predialytic) first, and next week shall receive the supplement at two hours after start (intradialytic) of dialysis session. Those in the afternoon shift, shall receive intradialytic oral supplement first and predialytic supplement next. Prior to the start of the study, a “run-in” period will be carried out to ensure adequate medication compliance and compulsory fasting of three hours prior to the oral supplement. All the patients will be dialysed on the same dialysis machines, with the same dialyzers and dialysis prescriptions on the two occasions. Blood sampling will be done once just prior to connecting to hemodialysis and then at two hours and end of hemodialysis. Spent dialysate will be continuously collected using partial dialysate collection technique. Blood pressures will be monitored every 30 minutes during the dialysis sessions. A questionnaire shall be filled by interviewing the patient at the end of the dialysis session, recording symptoms reported by the study subjects on a 5-point Likert scale. The symptoms to be recorded are: nausea and/or vomitings, bloating and lightheadedness. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. All stable patients of endstage renal disease between 18-70 years of age on maintenance hemodialysis for more than 3 months
2. Those on already prescribed oral protein supplementation
3. Providing informed consent for the study
 
 
ExclusionCriteria 
Details  Any episode of intradialytic hypotension in the last 1 month
History of recent cardiovascular events
History of recent gastrointestinal disturbances
Not fasting for at least 3 hours prior to start of study
Need for change in hemodialysis prescription due to any reason
Receiving any parenteral nutrition
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare hemodynamics, patient-reported adverse effects, dialysis efficacy and solute removal between predialysis and intradialytic oral high-protein nutritional supplementation  0 to 4 hours of the hemodialysis session 
 
Secondary Outcome  
Outcome  TimePoints 
None  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   31/05/2019 
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. Agarwal R, Georgianos P. Feeding during dialysis - risks and uncertainties. Nephrol Dial Transplant. 2014; 33: 917-922. 3. Kistler BM, Benner D, Burrows JD, et al. Eating during hemodialysis treatment: a consensus statement from the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2017; 10: 4-12. 6. Singri N, Johnstone D, Paparello J, et al. Effect of predialysis eating on measurement of urea reduction ratio and Kt/V. Adv Chronic Kidney Dis. 2004; 11: 398-403. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Nutritional management of patients with endstage renal disease is a challenging exercise for nephrologists, nutritionists and dialysis nurses, with a high unmet need for improving caloric and protein requirements, whilst balancing the inevitable increase in sodium, potassium and phosphorus intakes which accompanies nutrition supplementation.1 While it is common for nephrologists to prescribe protein supplements, compliance to these at prescribed doses is relatively low. Many dialysis patients in India are still unable to meet the high protein requirement and therefore, suffer from protein-energy wasting. In the light of the recent studies on feeding during hemodialysis which encourage intradialytic meal intake, and also an observation of regular intradialytic eating in several of our patients on hemodialysis, we designed this study to determine the optimal timing of oral nutrition supplementation.2.3 Hemodialysis is a catabolic state with substantial protein losses, depending on the technique and membrane parameters. Therefore, provision of directly observed high protein meal during hemodialysis or before it, can be beneficial in mitigating the muscle-wasting induced by hemodialysis.

Brief review:

A point of contention is the timing of oral nutrition supplements. Few studies done previously, have highlighted higher incidence of hypotensive episodes in those patients eating during hemodialysis, which is explained by splanchnic vasodilatation and fall in systemic vascular resistance.4,5 However, the effect of eating on hemodynamics during hemodialysis is inconsistent. The present study will also evaluate frequency of hypotensive episodes and the general tolerability of the hemodialysis when the patient has eaten. Another cause for concern is the observation of decreased dialysis efficacy as measured by Kt/V when intradialytic oral nutrition is provided.6,7 The fall in Kt/V in these studies is minimal and unlikely to cause clinical effects. Also, it is unclear from previous studies, whether urea is the only solute whose removal is affected by eating a high protein meal during dialysis, or does the effect extend to potassium and phosphorus removal as well. The present study will measure changes in serum levels of urea, potassium and phosphorus and also directly assess dialysate removal of these nutrients. By measuring dialysate removal of solutes, it can determine the safety of eating during hemodialysis, for patients with higher baseline urea, potassium and phosphorus.

Allowing for eating during hemodialysis is a policy matter which varies from unit to unit, and previous surveys conducted in the United States revealed that a substantial proportion of nephrologists support intradialytic eating.8 Certain practical aspects govern our institute’s policy for allowing eating during dialysis. First, many patients come from far-flung areas and may not find the time to prepare and consume a meal prior to coming for a dialysis session. Second, patients commonly report hunger after starting dialysis which can be mitigated by eating during dialysis. Ensuring consumption of a high calorie and high protein meal in a directly observed manner has previously shown improvement in nutritional parameters. 9


 
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