| CTRI Number |
CTRI/2025/09/094004 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Kidney Problems In Critically Ill Adults With Tropical Fever |
|
Scientific Title of Study
|
Clinical Characteristics and Outcomes Of Acute Kidney Injury in Critically Sick Adults with Tropical Acute Febrile Illness at a Tertiary Care Hospital in Western India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sankalp Ranjan |
| Designation |
DM Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Jaipur |
| Address |
Department of Critical Care Medicine,5th Floor,SRCC Building,Mahatma gandhi hospital,RICCO Industrial area,Sitapura,Jaipur,Rajasthan,
Jaipur
RAJASTHAN
302022
India |
| Phone |
6204652627 |
| Fax |
|
| Email |
drsankalpranjan08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srishti Jain |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Jaipur |
| Address |
B1001,Mahima Panache,Jagatpura,Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
7820895064 |
| Fax |
|
| Email |
srishti5484@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sankalp Ranjan |
| Designation |
DM Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital,Jaipur |
| Address |
Department of Critical Care Medicine,5th Floor,SRCC Building,Mahatma gandhi hospital,RICCO Industrial area,Sitapura,Jaipur,Rajasthan,
RAJASTHAN
302022
India |
| Phone |
6204652627 |
| Fax |
|
| Email |
drsankalpranjan08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical COllege and Hospital |
| Address |
Department of Critical Care Medicine |
| Type of Sponsor |
Private medical college |
|
|
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 Sankalp Ranjan |
Mahatma Gandhi Hospital, Jaipur |
MICU, Department Of Critical Care Medicine
Jaipur
RAJASTHAN |
6204652627
drsankalpranjan08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A90||Dengue fever [classical dengue], (2) ICD-10 Condition: A938||Other specified arthropod-borne viral fevers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
with confirmed tropical febrile illness admitted to ICU |
|
| ExclusionCriteria |
| Details |
Patients with CKD,Pre-existing renal dysfunction,Pregnant or Lactating women,End-of-Life care candidates |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Severity of AKI(Based on KDIGO criteria)
2)Outcomes of AKI(Mortality,Renal recovery,Dialysis requirment) |
1)Severity of AKI(Based on KDIGO criteria) on ICU Admission
2)Outcomes of AKI(Mortality,Renal recovery,Dialysis requirment) at the time of dicharge and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Laboratory & Diagnostic findings in AKI with TAFI
2)Risk factors for AKI development in critically ill patients with TAFI
3)Hospital & ICU stay duration |
1)Laboratory & Diagnostic findings in AKI with TAFI at the time of admission
2)Risk factors for AKI development in critically ill patients with TAFI at the time of admission
3)Hospital & ICU stay duration from the day of admission
|
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
25/09/2025 |
| 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="6"
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 prospective observational study will be conducted in the Department of Critical Care Medicine at Mahatma Gandhi Medical College and Hospital, Jaipur. It aims to describe the clinical characteristics and outcomes of acute kidney injury in critically ill adult patients admitted with tropical acute febrile illness such as malaria, dengue, scrub typhus and leptospirosis. A total of 65 patients aged between 18 and 65 years will be enrolled over a period of 18 months. Data will include clinical presentation, laboratory findings, severity of acute kidney injury based on KDIGO criteria, treatment details, and outcomes including renal recovery, duration of ICU and hospital stay, and mortality. The study will help identify risk factors and improve understanding of acute kidney injury in the context of tropical febrile illness in western India. |