| CTRI Number |
CTRI/2025/08/092250 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Emphysematous pyelonephritis at a Tertiary care Centre. |
|
Scientific Title of Study
|
Study of risk factors, clinical profile and outcomes of Emphysematous pyelonephritis at a Tertiary care Centre |
| Trial Acronym |
EPN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pakalapati Ananya |
| Designation |
Senior Resident |
| Affiliation |
Kasturba hospital, manipal |
| Address |
Department of Nephrology,
Kasturba hospital,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7396888888 |
| Fax |
|
| Email |
docananyapakalapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shankar Prasad N |
| Designation |
Professor |
| Affiliation |
Kasturba hospital, manipal |
| Address |
Department of Nephrology,
Kasturba hospital,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9739905443 |
| Fax |
|
| Email |
shankarmmcmed@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohan V Bhojaraja |
| Designation |
Associate Professor |
| Affiliation |
Kasturba hospital, manipal |
| Address |
Department of Nephrology,
Kasturba hospital,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Nephrology,
Kasturba Hospital,
Manipal,
Udupi, Karnataka
India - 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal |
| Address |
Department of Nephrology, Kasturba Hospital, Manipal, Udupi, Karnataka India - 576104 |
| 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 Pakalapati Ananya |
Kasturba Hospital, Manipal |
Department of Urology, Kasturba Hospital, Manipal, Udupi
Udupi
KARNATAKA |
7396888888
docananyapakalapati@gmail.com |
|
|
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: N10||Acute pyelonephritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted to the Department of Nephrology Urology and Medicine for management of EPN aged over 18 years |
|
| ExclusionCriteria |
| Details |
Patients with incomplete data or Patients who died of a suspected diagnosis of EPN before the diagnosis was confirmed or Patients who had an early transfer to another center after discontinuing treatment at the study center |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Renal outcomes: AKI, AKI requiring RRT, CKD (3 months follow up)
Duration of hospital stay
Requirement of surgical intervention for urinary diversion in the form of DJ stenting/ PCN insertion.
Mortality
|
At the time of admission and discharge.
At 1 month and 3 month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
18/08/2025 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study will be conducted ambispectively in KMCH, Manipal, MAHE, and the Department of Urology, Nephrology, and General Medicine. Patients admitted with the diagnosis of emphysematous pyelonephritis in the departments mentioned above during the study period will be included in the study as this is ambispective study consent for the patients who are enrolled prospectively will be taken, for the retrospective patient’s consent will be either taken when the patients come for follow-up. The patient data will be collected, including demographic details, medical history, examination, radiological imaging, Ultrasonography, CT scan, or MRI scan, along with blood investigations, which include both microbiology and pathological (CBC, RFT, Blood culture) and urine analysis with microscopy and urine culture—a requirement of surgical intervention for urinary diversion in the form of DJ stenting/ PCN insertion. Treatment is given, and the progress of the patient and follow-up will be recorded for both retrospective and prospective patients. The patient’s EPN characteristics will be analyzed in terms of patient demographics, clinical presentation, diagnostic investigations, microbiological findings, treatment modality, prognostic factors, and outcome. 10. Outcome measures: • Renal outcomes: AKI, AKI requiring RRT, CKD (3 months follow up) • Duration of hospital stay • Requirement of surgical intervention for urinary diversion in the form of DJ stenting/ PCN insertion. • Mortality • The patient data will be collected, including demographic details, medical history, examination, radiological imaging, Ultrasonography, CT scan, or MRI scan, along with blood investigations, which include both microbiology and pathological (CBC, RFT, Blood culture) and urine analysis with microscopy and urine culture. Treatment is given, and the progress of the patient and follow-up will be recorded for both retrospective and prospective patients. The patient’s EPN characteristics will be analyzed in terms of patient demographics, clinical presentation, diagnostic investigations, microbiological findings, treatment modality, prognostic factors, and outcome. |