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CTRI Number  CTRI/2024/11/077438 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 05/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Cholesterol and Fat Levels in People on Kidney Dialysis 
Scientific Title of Study   ANALYSIS OF DYSLIPIDEMIA AMONG HEMODIALYSIS PATIENTS A 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  Kadeejathul Azmiya CM 
Designation  Pharm D Student 
Affiliation  NGSM Institute of Pharamceutical Sciences,Deralakatte,Mangaluru 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru Dakshina Kannada KARNATAKA 575018 India
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9496274244  
Fax    
Email  azmiyamoideen@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharamceutical Sciences,Deralakatte,Mangaluru 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru Dakshina Kannada KARNATAKA 575018 India
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Roopa Satyanarayan Basutkar 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharamceutical Sciences,Deralakatte,Mangaluru 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru Dakshina Kannada KARNATAKA 575018 India
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
Justice K S Hegde Charitable Hospital, Derlakatte, Mangalore, Dakshina Kannada, Karnataka. Pin code- 575018 
 
Primary Sponsor  
Name  Justice K S Hegde Hospital 
Address  Hemodialysis Unit, Department of Nephrology, 3rd floor, K S Hegde hospital, Derlakatte, Mangalore 
Type of Sponsor  Private hospital/clinic 
 
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 Roopa Satyanarayan Basutkar  Justice K. S. Hegde Charitable Hospital  Hemodialysis Unit Department of Nephrology 3rd Floor Justice K S Hegde Hospital Deralakatte Mangalore
Dakshina Kannada
KARNATAKA 
9047155003

roopa.satyanarayan@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (2) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 years and above of both sexes.
2. Patients on hemodialysis for more than 6 months.
3. Patients willing to provide consent. 
 
ExclusionCriteria 
Details  1. Patients with active malignancy.
2. Patients with severe hepatic impairment.
3. Patients on peritoneal dialysis and
hemodiafiltration.
4. Familial hypertriglyceridemia.
5. Acute pancreatitis.
6. Patients on Anti-Hyperlipidemic and its
combination with other medications. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Routine laboratory parameters: Heamoglobin, Urea, eGFR, Creatinine, Potassium, calcium, phosphorous, RBS, Albumin, Alkaline phosphatase. Presence and absence of diabetes
Lipid Profile: Lipid profiles (HDL, LDL, TG, TC). Gender
Modified Charlson Comorbidity Index score Frequency of HD
Risk Factors:
Hypertension
BMI Anemia
eGFR Uremia
Social Habits: Smoking, Alcohol and others Comorbid conditions: CHD, stroke, Cirrhosis, Peripheral vascular disease, Hypertension, Diabetes
Duration on RRT
 
At baseline visit
 
 
Secondary Outcome  
Outcome  TimePoints 
Risk Factors:
Hypertension
BMI Anemia
eGFR Uremia
Social Habits: Smoking, Alcohol and others Comorbid conditions: CHD, stroke, Cirrhosis, Peripheral vascular disease, Hypertension, Diabetes Frequency of HD
Duration on RRT
 
At baseline visit 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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)   05/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Chronic kidney disease (CKD) is a major health burden that has a high morbidity and death rate and is steadily becoming more common. Worldwide, there are about 2. 6 million individuals receiving dialysis. Cardiovascular mortality is 10-20 times higher in patients on dialysis and accounting for over 50% of fatalities in this population than in the general population. Many studies have shown that patients on haemodialysis have elevated triglyceride and low HDL, these contribute to an increase in atherosclerotic risk. An independent risk factor and the primary cause of death for Individuals who undergoes dialysis, according to registry studies is cardiovascular disease (CVD) The patients undergoing haemodialysis have increased levels of atherogenic lipoprotein than non- uremic patients. Alteration in the lipoprotein levels in patients with hemodialysis will lead to atherosclerosis. The presence of CKD and diabetes with CVD have additive effects of worsening each other conditions, leading to an increase in morbidity and mortality.

Owing to the risk of Cardiovascular complications associated with CKD detection of dyslipidemia is important and prompt initiation of treatment with novel forms of therapy to manage blood pressure, dyslipidemia, and glucose levels is crucial. According to the KDIGO Guideline, in the general population, the treatment of dyslipidaemia is more rigorous but in CKD patients, the management is relatively. conservative regarding the diagnosis and treating with lipid lowering agents. Despite this recommendation, lipid levels are not assessed in CKD patients, this has largely attributed to lack of the high-quality evidence among the CKD patients and the overall feature of dyslipidaemia is considerably distinctive to that of the general population. Studies have shown that Lipid-lowering agents, can provide significant benefits for hemodialysis patients. Studies indicate a 25% reduction in mortality risk and a 12% decrease in major adverse cardiovascular events (MACES) among those using anti-dyslipidemia agents compared to non-users thus, there is limited information on dyslipidaemia among dialysis populations. In our study, we focus to determine the proportion of dyslipidemia and estimate mortality risk rate in HD patients. To compare lipid profile and determine the risk factors associated with the HD patients with T2DM and HD with non-T2DM patients.
 
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