| CTRI Number |
CTRI/2024/07/071029 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional status in patients undergoing maintenance hemodialysis |
|
Scientific Title of Study
|
Evaluation of Nutritional status in patients undergoing maintenance hemodialysis in a rural tertiary care hospital in Central India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranjal Kashiv |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Nephrology
Dialysis Room, 3rd Floor
Datta Meghe Institute of Higher Education and Research, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7999892968 |
| Fax |
|
| Email |
pranjalkashiv88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Pasari |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Nephrology
Dialysis Room, 3rd Floor
Datta Meghe Institute of Higher Education and Research, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422164630 |
| Fax |
|
| Email |
dramit2811@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Pasari |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Nephrology
Dialysis Room, 3rd Floor
Datta Meghe Institute of Higher Education and Research, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422164630 |
| Fax |
|
| Email |
dramit2811@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, 442001, India |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 pranjal kashiv |
Datta Meghe Institute of Higher Education and Research |
Department of Nephrology
Dialysis Room, 3rd Floor
Wardha
MAHARASHTRA |
7999892968
pranjalkashiv88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences, Sawangi (Meghe), Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. Patient should have been on regular haemodialysis for at least 3 months |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years 2. patients with active infection at the time of study 3. history of admission to the hospital in the past three months 4. alcoholism 5. acute renal failure 6. cancer 7. major adverse cardiovascular events 8. severe gastrointestinal and hepatic diseases 9. Poor compliance with dialysis treatment, defined as skipping more than one session of haemodialysis in the preceding 4 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of Malnutrition in Patients Undergoing MHD:
- Measure: Percentage of patients categorized into different nutritional status groups (normal nutrition, mild-to-moderate malnutrition, severe malnutrition) using the Modified Quantitative Subjective Global Assessment (MQSGA) tool.
2. Change in Nutritional Status Over Time:
- Measure: Change in MQSGA scores from baseline to follow-up points.
|
At the time of enrollment, mid-study (6 months), and at the end of the study (1.5 years). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Anthropometric Measurements:
-Measure: Changes in body mass index (BMI), mid-arm circumference (MAC), mid-arm muscle circumference (MAMC), triceps skin fold (TSF), & biceps skin fold (BSF).
2. Biochemical Markers:
-Measure: Changes in serum albumin, total protein, urea, creatinine, calcium, phosphate, lipid profile, & qualitative C-reactive protein (CRP).
|
At the time of enrollment, mid-study (6 months), & at the end of the study (1.5 years). |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to evaluate the nutritional status of patients undergoing maintenance hemodialysis (MHD) in a rural tertiary care hospital in central India, addressing the high prevalence of malnutrition, particularly protein-energy malnutrition (PEM), among this population. Conducted over 1.5 years at Acharya Vinoba Bhave Rural Hospital, the study involves 200 participants and employs the Modified Quantitative Subjective Global Assessment (MQSGA) tool to assess nutritional status. The primary outcomes include the prevalence and changes in malnutrition status, while secondary outcomes focus on anthropometric measurements, biochemical markers, dietary intake, quality of life, and hospitalization and mortality rates. This research underscores the critical need for routine nutritional assessments in MHD patients to enhance their quality of life and survival, providing valuable insights into effective nutritional screening and management practices in the Indian healthcare context. |