| CTRI Number |
CTRI/2025/01/079819 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical features and renal functional abnormalities in patients with Acute febrile illness |
|
Scientific Title of Study
|
To study the clinical features and renal functional abnormalities in Acute febrile illness |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karan Parikh |
| Designation |
Resident |
| Affiliation |
Dr D Y patil school of medicine |
| Address |
Aiyappa temple road, DR D Y patil vidhyanagar, sector 5 , nerul, navi mumbai, Maharashtra-400706
Thane
MAHARASHTRA
400706
India |
| Phone |
08779396922 |
| Fax |
|
| Email |
karanparikh7398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Bhate |
| Designation |
Professor |
| Affiliation |
Dr D Y patil school of medicine |
| Address |
Aiyappa temple road, DR D Y patil vidhyanagar, sector 5 , nerul, navi mumbai, Maharashtra-400706
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9821366812 |
| Fax |
|
| Email |
archbhate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karan Parikh |
| Designation |
Resident |
| Affiliation |
Dr D Y patil school of medicine |
| Address |
2202 vighnahar heights off palm beach service road sector 14 nerul West navi Mumbai
Aiyappa temple road, DR D Y patil vidhyanagar, sector 5 , nerul, navi mumbai, Maharashtra-400706
MAHARASHTRA
400706
India |
| Phone |
08779396922 |
| Fax |
|
| Email |
karanparikh7398@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College and hospital, Nerul, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Karan parikh |
| Address |
Junior Resident, Department of General Medicine, Dr D.Y Patil Medical College, Navi Mumbai-400706 |
| Type of Sponsor |
Other [] |
|
|
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 Karan Parikh |
Dr DY Patil Hospital |
OPD-1 (General Medicine OPD, Female Medicine ward , Male Medicine ward, Intensive Care Unit, DR DY patil Hospital Nerul , Navi Mumbai
Thane
MAHARASHTRA |
8779396922
Karanparikh7398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Heath Research, DR DY PATIL Medical College, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age greater than 18 years of age
All patients with Acute febrile illness ( malaria, dengue fever, scrub typhus , enteric fever, leptospirosis, undiagnosed fever )
|
|
| ExclusionCriteria |
| Details |
Patients with past history of renal disease
Patients with long term use of Nephrotoxic drugs
Patients less than 18 years of age
Pregnant females
Recent alternative identifiable cause of acute kidney injury
Administrative Matters
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the clinical features and renal biochemical profile in Acute febrile illness |
Baseline 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence & outcome of acute kidney injury in all patients with acute febrile illness admitted in a tertiary care center |
Baseline 1 year |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
14/02/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Study title: To study the clinical features and renal function abnormalities in Acute febrile illness. Acute kidney injury (AKI) is defined by the impairment Of kidney and excretory function over days to weeks resulting in retention of nitrogenous and other waste products normally cleared by the kidneys. AKI increases the risk of development or worsening of CKD. Patients recovering from AKI requiring dialysis are at increased risk of developing dialysis requiring end stage renal disease in the future. Acute febrile illness is defined as fever of duration < 2 weeks , rapid onset caused by diverse pathogens without any system/ organ specific etiology. AKI is a major cause of mortality among patients with AFI. The spectrum of AFI includes malaria , dengue, Typhoid fever, leptospirosis , scrub typhus. Assessment in the changes of renal biochemical profile can help to prevent end stage renal disease and hence this study is being undertaken to determine the incidence and outcome of AKI among all the patients admitted with commonly occurring Acute febrile illness.
|