| CTRI Number |
CTRI/2025/02/081204 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Of Early Outcomes In Patients Newly Initiated On Hemodialysis |
|
Scientific Title of Study
|
Early Outcomes In Patients Newly Initiated On Hemodialysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hardik Sheth |
| Designation |
Resident |
| Affiliation |
D Y Patil University School of Medicine |
| Address |
401, KRISHNA KUNJ, V. M. ROAD, JUHU SCHEME, Vile parle west Department of General Medicine, 3rd floor, D Y Patil Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 Thane MAHARASHTRA 400056 India |
| Phone |
9930496869 |
| Fax |
|
| Email |
hardiksheth94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prashant Purkar |
| Designation |
Professor |
| Affiliation |
D Y Patil University School of Medicine |
| Address |
Department of General Medicine, 3rd floor, D Y Patil Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane MAHARASHTRA 400706 India |
| Phone |
9975498808 |
| Fax |
|
| Email |
prashpurkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prashant Purkar |
| Designation |
Professor |
| Affiliation |
D Y Patil University School of Medicine |
| Address |
Department of General Medicine, 3rd floor, D Y Patil Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane MAHARASHTRA 400706 India |
| Phone |
9975498808 |
| Fax |
|
| Email |
prashpurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra, India 400706 |
|
|
Primary Sponsor
|
| Name |
Hardik Sheth |
| Address |
D Y Patil Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 |
| 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 Hardik Sheth |
D Y Patil Hospital |
Department of General Medicine, 3rd Floor, D Y Patil Hospital, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 Thane MAHARASHTRA |
02227735901
hardiksheth94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N258||Other disorders resulting from impaired renal tubular function, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. All indoor and outdoor patients newly initiated on hemodialysis
2. Age more than 18 years
3. Willing to give consent
|
|
| ExclusionCriteria |
| Details |
1. Patients already on hemodialysis
2. Patients with age more than years are excluded from the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the early outcomes in patients newly initiated on Hemodialysis. |
One year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Study the various complications associated with initiating hemodialysis.
2. To evaluate clinical profile of patient newly initiated on hemodialysis.
3. Corelation of clinical profile and investigations of these patients
|
14 months |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
05/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Renal replacement therapies include hemodialysis, peritoneal dialysis and Renal transplant. Hemodialysis is an extracorporeal process of removing waste products like free water, creatinine and urea, thus maintaining homeostasis in a state of kidney failure.[1] There are 3 types of dialysis – Slow (or sustained) low efficiency daily dialysis, Continuous renal replacement therapy, Intermittent hemodialysis. The basic principle behind dialysis is diffusion of solutes through a semipermeable membrane. This is achieved by countercurrent flow which helps keep dialysate and blood flowing in opposite direction, thus achieving a gradient across the membrane while attaining maximum efficiency of dialysis. Free water removal is achieved by ultrafiltration, a process of altering the hydrostatic pressure of the dialysate compartment, causing free water and some dissolved solutes to move across the membrane along a created pressure gradient. Dialysate, the main dialysis solution has a sodium and chloride content similar to that of plasma while having slightly higher levels of bicarbonate and glucose to compensate for metabolic acidosis and hypoglycemia respectively. The electrolyte content of the dialysate can be adjusted to compensate for dyselectrolytemia. [2] Hemodialysis may result in complications such as: · Fluid shifts – occurs when fluid is removed too rapidly or large amount of fluid is removed. This leads to common side effects like hypotension, hypertension, cramps, headache, nausea/vomiting, fatigue, chest pain, etc. These symptoms are commonly refered to as dialysis hangover/washout. · First use syndrome – is a rare but severe anaphylactic reaction to the components of dialysis mainly the dialyser filaments or the chemical sterilants used to sterilize it. [3] · Dialysis disequilibrium syndrome – a neurological syndrome mostly associated with patients newly initiated on hemodialysis or those who have missed multiple cycles. Caused by reverse urea effect due to rapid removal of urea or intracerebral acidosis. Symptoms include headache, nausea, blurred vision, dizziness, muscle cramps, seizure, somnolence, stupor, or coma which can even lead to death in severe cases.[4] · Electrolyte imbalance – Mainly causing imbalance in potassium (hyperkalemia or hypokalemia) and sodium (hyponatremia or hyponatremia) levels. This greatly increases the risk of cardiovascular deaths.[5] · Cardiovascular complications – one of the most common complications associated with hemodialysis. Complications include arrhythmias of which diaysis associated complex ventricular arrhythmia is the most common. There is limited data available on complications of newly initiated dialysis patients especially in Indian population. Through this study we analyse the various complications associated with initiating dialysis, outcomes of patients after initiation, and correlate the clinical profile of these patients with various laboratory investigations. |