| CTRI Number |
CTRI/2018/09/015849 [Registered on: 26/09/2018] Trial Registered Prospectively |
| Last Modified On: |
26/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
RISK FACTORS FOR KIDNEY DAMAGE IN LEPTOSPIROSIS INFECTION |
|
Scientific Title of Study
|
RISK FACTORS FOR ACUTE KIDNEY INJURY (AKI) IN LEPTOSPIROSIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S BHAVANA |
| Designation |
POST GRADUATE |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF MEDICINE, KASTURBA MEDICAL COLLEGE, KASTURBA HOSPITAL, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8801636266 |
| Fax |
|
| Email |
bhavana.surapareddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRMURALIDHAR VARMA |
| Designation |
ASSOCIATE PROFESSOR , MEDICINE |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF MEDICINE, KASTURBA MEDICAL COLLEGE, KASTURBA HOSPITAL, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8801636266 |
| Fax |
|
| Email |
drmuralidharvarma@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
S BHAVANA |
| Designation |
POST GRADUATE |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF MEDICINE, KASTURBA MEDICAL COLLEGE, KASTURBA HOSPITAL, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8801636266 |
| Fax |
|
| Email |
bhavana.surapareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA HOSPITAL, MANIPAL |
|
|
Primary Sponsor
|
| Name |
S BHAVANA |
| Address |
DEPARTMENT OF MEDICINE, KASTURBA MEDICAL COLLEGE, KASTURBA HOSPITAL, MANIPAL |
| 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 |
| SBHAVANA |
KASTURBA HOSPITAL |
ROOM NO 11, DEPARTMENT OF GENERAL MEDICINE
MANIPAL
Udupi
KARNATAKA |
8801636266
bhavana.surapareddy@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: A27||Leptospirosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
CASE:Confirmed cases of Leptospirosis associated with Acute kidney injury as per
KDIGO definition.
CONTROL:Patients diagnosed as Leptospirosis and who did not develop AKI as
per KDIGO criteria. |
|
| ExclusionCriteria |
| Details |
All other acute febrile illnesses except leptospirosis.
Cases of Leptospirosis with other coinfections (which may independently lead to
AKI) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Full recovery and cure from illness or Death due to complications at discharge
|
At discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality in Leptospirosis |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/10/2018 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary objective of the study is to find risk factors for development of AKI- acute kidney injury in cases of Leptospirosis by correlational analysis. Secondary objective is to look for predictors of mortality and calculate mortality rate in cases of Leptospirosis. In other similar studies, factors like leucocytosis, hyperbilirubinemia, hyperkalemia were found to be predictive of development of AKI in patients with Leptospirosis. |