| 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
|
|
|
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
|
|
|
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 |