| CTRI Number |
CTRI/2022/05/042733 [Registered on: 23/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study cardiac related problems in kidney disorder patient |
|
Scientific Title of Study
|
Study of cardiac abnormalities in chronic kidney disease utilising echocardiography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saiprasad Kharat |
| Designation |
PG Scholar |
| Affiliation |
School of medicine,Dr.D.Y.Patil deemed to be university |
| Address |
Department of medicine,School of medicine,Dr.D.Y.Patil Hospital and deemed to be university,sector-5,Navi Mumbai
Thane
Maharashtra
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9673752021 |
| Fax |
|
| Email |
saikharat.18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saiprasad Kharat |
| Designation |
PG Scholar |
| Affiliation |
School of medicine,Dr.D.Y.Patil deemed to be university |
| Address |
Department of medicine,School of medicine,Dr.D.Y.Patil Hospital and deemed to be university,sector-5,Navi Mumbai
Thane
Maharashtra
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9673752021 |
| Fax |
|
| Email |
saikharat.18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrashant Purkar |
| Designation |
Professor |
| Affiliation |
School of medicine,Dr.D.Y.Patil deemed to be university |
| Address |
Department of medicine,School of medicine,Dr.D.Y.Patil Hospital and deemed to be university,sector-5,Navi Mumbai
Thane
Maharashtra
400706
India
Thane
MAHARASHTRA
400706
India |
| Phone |
9975498808 |
| Fax |
|
| Email |
Prashpurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of medicine,Dr.D.Y.Patil deemed to be university |
|
|
Primary Sponsor
|
| Name |
DrSaiprasad Kharat |
| Address |
Department of Medicine,school of Medicine,Dr.D.Y.Patil Hospital and deemed to be university,sector-5 Nerul,Navi Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
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 Saiprasad Kharat |
School of medicine,Dr.D.Y.Patil,D.Y. Patil deemed to be university. |
Department of medicine,School of medicine,Dr.D.Y.Patil hospital and deemed to be university ,sector-5,Nerul,Navi Mumbai
Maharashtra
Thane
400706
Thane
MAHARASHTRA |
9673752021
saikharat.18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)patient who with known chronic kidney disease
2)patients who are symptomatic for 3 months and above
3jpatients with serum creatinine levels >3mg% and creatinine clearance <30 ml/min
4)patients with bilateral contracted kidney on abdominal Usg with poor corticomedullary differentiation and type 2 or type 3 parenchymal changes.patients with autosomal poly cystic kidney disease and obstructive Nephro Pathy are also included In the study though they do not have any contracted kidney due to the underlying disorder |
|
| ExclusionCriteria |
| Details |
1)patients who are known to have valvular heart disease,coronary heart disease
2)patients who are known hypertensive for years before the onset of chronic kidney disease
3)patient who were undergoing dialysis after admission
4)patients above 75 yrs of age
5)patients who are alcoholics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) to study the cardiac changes and complications in patients with chronic kidney disease
|
0-1 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the incidence of left ventricular dysfunction,concentric left ventricular hypertrophy ,pericardial effusion in chronic kidney disease using echocardiography |
0-1years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/05/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is the clinical observational study for completion under D y Patil deemed to be university Total duration of trial 1 yr
Title-To study the cardiac abnormalities in chronic kidney disease using echocardiography
Study group :sample size -60
Study centre: D y Patil deemed to be university,Navi Mumbai
PG scholar-Saiprasad Uttam Kharat
Guide-Dr Prashant Purkar |