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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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