| 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
|
|
|
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
|
| 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 |