| CTRI Number |
CTRI/2023/11/060127 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
20/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The amount of fluid in patients receiving routine hemodialysis treatment is measured by using body composition monitor. |
|
Scientific Title of Study
|
Assessment of body fluid status in maintenance hemodialysis patients using Body Composition Monitor. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Harihar |
| Designation |
Student |
| Affiliation |
Manipal College Of Health professionals, Manipal Academy Of Higher Education, Karnataka, India. |
| Address |
M.sc Renal Replacement Therapy and Dialysis Technology.
Manipal college of health professionals, MAHE, Manipal.
Nephrology Of Nephrology, Manipal College Of Health professionals, Manipal Academy Of Higher Education, Karnataka, India-576104.
Udupi
KARNATAKA
576104
India |
| Phone |
9980427620 |
| Fax |
|
| Email |
vinayjoseph882@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan VB |
| Designation |
Associate professor |
| Affiliation |
Kasturba Hospital Manipal, Manipal Academy Of Higher Education, Karnataka, India. |
| Address |
First floor, Unit-2,
Department Of Nephrology, Kasturba Hospital Manipal, Manipal Academy Of Higher Education, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Ajith M Nayak |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Hospital Manipal, Manipal Academy Of Higher Education, Karnataka, India. |
| Address |
5th floor, Renal Replacement Therapy and Dialysis Technology, Manipal College Of Heath Professions, Manipal Academy Of Higher Education, Manipal, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
ajith.mnayak@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department Of Nephrology, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Karnataka, India-576104. |
|
|
Primary Sponsor
|
| Name |
Vinay Harihar |
| Address |
Department Of Nephrology, Manipal College Of Health Professionals, Manipal Academy Of Higher Education, Karnataka, India-576104 |
| Type of Sponsor |
Other [Self (principal investigator)] |
|
|
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 |
| Vinay Harihar |
Kasturba hospital Manipal. |
Dialysis Unit, 3rd Floor, Department of Nephrology, Udupi, Karnataka, India-576104
Udupi
KARNATAKA |
9980427620
vinayjoseph882@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethical Committee-2 Student Research) |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age greater than 18 years.
At least on twice weekly hemodialysis more than 3 months. |
|
| ExclusionCriteria |
| Details |
Individual with pacemaker, Metallic joints/pins/clips and amputated major limb.
Patients on Peritoneal dialysis, patients with acute kidney injury. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the body fluid status in maintenance hemodialysis patients using a Body Composition Monitor. |
Outcome will be assessed at baseline soon after CTRI approval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the mean pre-hemodialysis blood pressure level of patients in the overhydration group, normal hydration group, & underhydration group. |
Outcome will be assessed at baseline soon after CTRI approval. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/12/2023 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Total body water is comprised of about 50%-60% of adult human weight intra cellular fluid is about 40% of total body weight and extracellular fluid is about 20% patients on hemodialysis the estimation of fluid status is very important as euvolemia serves as the foundation for dry weight the exact identification of fluid status in hemodialysis patients is a man task for doctors fluid overload in hemodialysis patients is linked to negative outcomes hypertension and chronic fluid overload are two of the main factors that contribute to death in dialysis patients according to studies fluid status in dialysis patients may be properly assessed and managed to help blood pressure under control Body Composition Monitor is a straightforward inexpensive and non-invasive test that may be used to determine overhydration in hemodialysis patients Body composition monitor device operate at 50 frequency to measure impedance spectroscopy fluid status is assessed in the supine position the absolute fluid overload will be between -1 to +1 for a normal hydration patient cardioprotective hemodialysis can be benefit from bio impedance guided management’s benefits for hemodialysis patients better results are linked to maintaining normal hydration level and avoiding greater ultrafiltration rates fluid estimation which uses the BCM as its primary part can regulate a patients fluid status which may results in lower mortality improved hypertension management and a need for less antihypertensive medications. |