| CTRI Number |
CTRI/2024/07/070793 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of ECG changes after a Session of Hemodialysis. |
|
Scientific Title of Study
|
Evaluation of changes in Electrocardiographic Parameters Following a Session of Hemodialysis among the patients of Renal Failure admitted in Tertiary Care Center. |
| 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 Krishnadev Gohil |
| Designation |
Post Graduate 2nd year resident |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Opd no. 62, Medicine department, Sir Takhatsinhji Hospital Campus,Bhavnagar-364001 Sir T Hospital, Bhavnagar, Gujarat.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9106108883 |
| Fax |
02782422011 |
| Email |
kdgohil1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Panna Kamdar |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Department of Medicine, Medical College and Sir T Hospital, Bhavnagar, Gujarat, India Sir T Hospital,Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
09106108883 |
| Fax |
02782422011 |
| Email |
drpam2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Panna Kamdar |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Department of Medicine, Medical College and Sir T Hospital, Bhavnagar, Gujarat, India Sir T Hospital,Bhavnagar, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
09106108883 |
| Fax |
02782422011 |
| Email |
drpam2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Sir Takhatsinhji General Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Krishnadev Gohil |
| Address |
Opd no. 62, Department of Medicine, Sir Takhatsinhji General Hospital ,Bhavnagar-364001, Gujarat. |
| 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 Krishnadev Gohil |
Sir Takhatsinhji General Hospital, Bhavnagar |
Sir Takhatsinhji General Hospital,General Medicine Department,Medicine Unit-D,Bhavnagar-364001, Gujarat
Bhavnagar
GUJARAT |
9106108883
02782422011
kdgohil1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Government Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N10-N16||Renal tubulo-interstitial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Chronic Kidney Disease and Acute Renal Failure requiring Hemodialysis according to KDIGO Guidelines of age more than 18 years admitted on Thursday in Tertiary care Hospital. |
|
| ExclusionCriteria |
| Details |
1.Patients with recent history of Myocardial Infarction less than 3 months back
2.acute coronary syndrome less than 3 months back
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of changes in Electrocardiographic Parameters Following a Session of Hemodialysis among the patients of Renal Failure admitted in Tertiary Care Center. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Association of Etiology of Renal failure with Electrocardiographic parameters after a session of hemodialysis
2. Evaluation of changes in Renal Function markers and Electrolytes after a session of Hemodialysis
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/07/2024 |
| 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="8"
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
|
This study is Before-and-After Observational study for evaluation of changes in Electrocardiographic Parameters following a Session of Hemodialysis among the patients of Renal Failure admitted in Tertiary Care Center. |