| CTRI Number |
CTRI/2025/09/094081 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Artificial Intelligence to predict outcomes in patients with severe tropical fevers such as Dengue and Leptospirosis requiring dialysis treatment |
|
Scientific Title of Study
|
AI-Based Predictive Modeling for Clinical Outcomes in Tropical Febrile Illnesses requiring CRRT: A Retrospective Observational Study |
| 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 ABHISHEK R |
| Designation |
PROFESSOR |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar, Meppadi (PO), Wayanad
Naseera Nagar,
Meppadi (PO),Wayanad,
Kerala, India
Naseera Nagar,
Meppadi (PO),Wayanad
Wayanad
KERALA
673577
India |
| Phone |
07795460038 |
| Fax |
|
| Email |
dr.abhishek.rajanaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethi RN |
| Designation |
Assistant Professor |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar, Meppadi (PO), Wayanad
Naseera Nagar,
Meppadi (PO),Wayanad,
Kerala, India
Naseera Nagar,
Meppadi (PO),Wayanad
Wayanad
KERALA
673577
India |
| Phone |
8277623335 |
| Fax |
|
| Email |
preethi9010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ABHISHEK R |
| Designation |
PROFESSOR |
| Affiliation |
Dr Moopens Medical College |
| Address |
Department of Anaesthesiology, Dr Moopens Medical College, Naseera Nagar, Meppadi (PO), Wayanad
Naseera Nagar,
Meppadi (PO),Wayanad,
Kerala, India
Naseera Nagar,
Meppadi (PO),Wayanad
Wayanad
KERALA
673577
India |
| Phone |
07795460038 |
| Fax |
|
| Email |
dr.abhishek.rajanaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Moopens Medical College, Naseera Nagar,
Meppadi (P.O),Wayanad,
Kerala, India
Pin- 673577 |
|
|
Primary Sponsor
|
| Name |
Dr Moopens Medical College |
| Address |
Dr Moopens Medical College, Naseera Nagar, Meppadi (PO),Wayanad, Kerala, India.
Pin code- 673577 |
| 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 Abhishek R |
Dr Moopens Medical College |
Department of Anaesthesiology, 7th floor, Naseera Nagar, Meppadi (P.O),Wayanad, Kerala, India.
Pin code- 673577
Wayanad
KERALA |
7795460038
dr.abhishek.rajanaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Moopens Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
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 |
Patients aged 18 to 65 years
Diagnosis of tropical fever (Leptospirosis & Dengue)
Thrombocytopenia (platelets less than 1,00,000/mm³)
Received ICU care
|
|
| ExclusionCriteria |
| Details |
Chronic kidney disease prior to admission
Prior Thrombocytopenia secondary to Hematological causes
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of CRRT in reducing mortality and improving renal recovery in patients with tropical fever presenting with thrombocytopenia. |
Baseline values will be recorded on admission to the ICU as time zero, followed by 24 hours, 48 hours and 72 hours and 4 weeks after dscharge from the ICU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Predict the need for CRRT.
2. Predict patient outcomes (recovery vs mortality).
3. To identify clinical & laboratory parameters that influence CRRT outcomes.
4. To compare CRRT vs non-CRRT patient outcomes in matched cohorts.
|
Baseline values will be recorded on admission to the ICU as time zero,
followed by 24 hours, 48 hours & 72 hours & 4 weeks after dscharge from the ICU. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
06/10/2025 |
| 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)
|
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
|
Tropical febrile illnesses such as Dengue and Leptospirosis are common in endemic regions such as Wayanad, Kerala and often present with thrombocytopenia and acute kidney injury (AKI). ContinUous renal replacement therapy (CRRT) has been life-saving in many such cases, but predictors of response and outcomes remain unclear. AI can help identify patterns, predict disease progression, and support early intervention strategies. |