FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074380 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 14/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between administration of continuous saline drip vs intermittent saline drip during dialysis in preventing clot formation in dialysis tubing in patients who undergo dialysis without heparin. 
Scientific Title of Study   Comparison between Continuous Saline Infusion and Intermittent Saline Flushing in preventing clot formation of Extracorporeal circuit in heparin free 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  Sahil Kharbanda 
Designation  Senior Resident, Department of Nephrology 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh  
Address  Department of Nephrology, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7727933322  
Fax    
Email  sahilkharbanda2010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. H.S. Kohli 
Designation  Professor and Head of Department 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh  
Address  Department of Nephrology, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9417525285  
Fax    
Email  kohlihs2009@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sahil Kharbanda 
Designation  Senior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh  
Address  Department of Nephrology,Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7727933322  
Fax    
Email  sahilkharbanda2010@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research,Sector-12,Chandigarh Pin-160012,India  
 
Primary Sponsor  
Name  Sahil Kharbanda 
Address  Senior Resident, Department of Nephrology,Post Graduate Institute of Medical Education and Research,Sector-12,Chandigarh Pin-160012,India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sahil Kharbanda  PGIMER, Chandigarh  Department of Nephrology, PGIMER Chandigarh
Chandigarh
CHANDIGARH 		 7727933322

sahilkharbanda2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER, Chandigarh Institutional Ethics Committee(Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N179||Acute kidney failure, unspecified, (2) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Continuous Saline Infusion  0.9% Normal saline will given continuously via infusion at fixed rate of 200 ml/hour for total 4 hours of dialysis 
Comparator Agent  Intermittent Saline Flushing  0.9% normal saline will be given as intermittent bolus as 100 ml every 30 mins for total 4 hours of dialysis 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients undergoing heparin free hemodialysis 
 
ExclusionCriteria 
Details  1.Patients requiring transfusion of blood products.
2.Patients suffering from a known thrombophilic state.
3.Patients who will be prescribed hemodialysis session for duration less than 4 hours.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Clotting of Extracorporeal circuit rendering dialysis impossible to continue i.e Grade 4 clotting  Every 30 minutes into dialysis 
 
Secondary Outcome  
Outcome  TimePoints 
Grade 1 to 3 clotting  Every 30 minutes into dialysis 
Blood flow rate, time into the dialysis when clotting develops in both the groups  Every 30 minutes into dialysis 
New onset clinical complications, as noted by the treating team, for upto 24 hours after the dialysis session  Upto 24 hours after the dialysis session 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
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)   25/09/2024 
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="0"
Months="2"
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   This is a randomized parallel group open label, single centre study comparing continuous saline infusion and intermittent saline flushing methods in preventing clot formation during heparin free hemodialysis. The primary outcome would be grade 4 clotting of extracorporeal circuit and secondary outcome would be grade 1 to 3 clotting, blood flow rate and time into the dialysis when clotting develops and new onset clinical complication upto 24 hours after dialysis session. 
Close