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CTRI Number  CTRI/2024/05/067598 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 17/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To check for dyslipidemia in chronic kidney disease Patients 
Scientific Title of Study   Assessment of lipid profile changes in chronic kidney disease patients : Cross-sectional study 
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.Akshay Kukade 
Designation  Junior resident  
Affiliation  D Y Patil university school of medicine navi mumbai 
Address  Medicine department , Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  9987030561  
Fax    
Email  akskuk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Prashant Purkar 
Designation  Professor 
Affiliation  D Y Patil university school of medicine, navi mumbai 
Address  Medicine department , Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  9892971979  
Fax    
Email  prashpurkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Prashant Purkar 
Designation  Professor 
Affiliation  D Y Patil university school of medicine, Navi Mumbai 
Address  Medicine department , Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400706
India 
Phone  9892971979  
Fax    
Email  prashpurkar@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil university school of medicine, Navi Mumbai 
 
Primary Sponsor  
Name  D Y Patil university school of medicine Navi Mumbai 
Address  Medicine Department, Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 
Type of Sponsor  Private medical college 
 
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 Akshay Kukade  D Y Patil Hospital  Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 
9987030561

akskuk@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: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  All patients of Chronic Kidney Disease with age 18 years or above, who give consent for study 
 
ExclusionCriteria 
Details  Patients who do not fill the above criteria.
Patients with renal transplant.
Patients with nephrotic syndrome.
Pregnant Female patients.
Immunocompromised patients.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in HDL and Increase in LDL,TC,TG,VLDL IN CKD patients on Hemodialysis compared to CKD patients on conservative management  lipid profile sent at baseline on presentation to hospital  
 
Secondary Outcome     
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   28/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/05/2024 
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  

·       Cardiovascular disease (CVD) is a major cause of mortality in patients with mild to moderate chronic kidney disease (CKD) and end stage renal disease (ESRD.

·       Hyperlipidemia, one of the important risk factors of atherosclerosis, is an abnormality commonly encountered in patients with chronic kidney disease.

·       Patients with chronic kidney disease have other risk factor includes hypertension, diabetes mellitus, smoking, and obesity

·       Previous Studies demonstrates that CRF is commonly accompanied by lipid abnormality in the form of Hypertriglyceridemia

·       The present study is undertaken to explore the altered lipid abnormalities in CKD from stage I to stage V classified as per National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKFK/DOQI) guidelines, which plays a vital role in development of atherosclerotic cardiovascular disease.

·       An attempt is made to correlate the clinical features with biochemical profile to classify the etiology and outcome on the hospitalized patients.


a.     Eligibility Criteria:

   Inclusion:

   All patients of Chronic Kidney Disease with  age  18  years  or  above,  who  give consent for study

   Exclusion Criteria

   Patients who do not fill the above criteria.

   Patients with renal transplant.

   Patients with nephrotic syndrome.

   Pregnant Female patients.

   Immunocompromised patients.


 Provisional Conclusion :

Decrease in hdl level and increase in ldl,vldl,tg,tc in ckd patients on hemodialysis as compared to ckd patients on conservative management


 
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