| 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
|
|
|
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
|
|
|
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
|
|
|
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. |