| CTRI Number |
CTRI/2024/10/075746 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Monkey Disease and kidney disease |
|
Scientific Title of Study
|
Incidence of acute kidney injury and their outcome in Kyasanur Forest disease patient |
| 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 Ravindra Prabhu Attur |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room number-15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Prabhu Attur |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room number-15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India
KARNATAKA
576104
India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Prabhu Attur |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room number-15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India
KARNATAKA
576104
India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra Prabhu Attur |
Kasturba Medical College, Manipal |
Room number-15, Department of Nephrology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9448107771
ravindra.prabhu@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A982||Kyasanur Forest disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All gender patients between 18-80 years |
|
| ExclusionCriteria |
| Details |
Patients who is not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will be helpful to understand the effect of KFD on kidney function and related mortality. |
Starting of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
At 6 months |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
01/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aims to observe the incidence of acute
kidney injury (AKI) in patients with Kyasanur Forest Disease (KFD), also known
as monkey fever. And to observe the
long-term outcome of AKI (recover, chronic kidney disease (CKD), end stage
renal disease (ESRD), Mortality).
|