| CTRI Number |
CTRI/2024/12/078229 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Understand the Role of Double J Stenting in Managing Acute Kidney Infections (Acute Pyelonephritis) |
|
Scientific Title of Study
|
A prospective, two arm, observational study to analyze the factors predicting the role of double J stenting technique in management of acute pyelonephritis. |
| 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 Vikash Kumar |
| Designation |
HOD of Urology Department and Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No. 08, First floor, Department of Urology, Shrishti Complex, Bhaktivedanta Swami Marg, Mira road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9820163302 |
| Fax |
|
| Email |
drvikash.k@bhaktivedantahospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikash Kumar |
| Designation |
HOD of Urology Department and Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No. 08, First floor, Department of Urology, Shrishti Complex, Bhaktivedanta Swami Marg, Mira road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9820163302 |
| Fax |
|
| Email |
drvikash.k@bhaktivedantahospital.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikash Kumar |
| Designation |
HOD of Urology Department and Consultant Urologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
OPD No. 08, First floor, Department of Urology, Shrishti Complex, Bhaktivedanta Swami Marg, Mira road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA
401107
India |
| Phone |
9820163302 |
| Fax |
|
| Email |
drvikash.k@bhaktivedantahospital.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute , Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vikash Kumar |
Bhaktivedanta Hospital and Research Institute |
OPd No. 08, First Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA |
9820163302
drvikash.k@bhaktivedantahospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research |
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 |
| Comparator Agent |
Conservative Antibiotic Treatment |
• Patients presenting with symptoms such as fever, chills, flank pain, nausea, vomiting, burning micturition, and dysuria will be evaluated using standard imaging studies, including Ultrasound KUB or Computed Tomography (CT) KUB. The interpretation of imaging findings suggestive of acute pyelonephritis will be reviewed by a consultant urologist to confirm the diagnosis.
• Patients who receive standard conservative antibiotic treatment, typically involving broad-spectrum antibiotics such as beta-lactams or third-generation cephalosporins with or without aminoglycosides, will be enrolled in Group A (Standard of Care Conservative Treatment). The duration of standard conservative treatment is one week from the time of diagnosis.
|
| Intervention |
Double J Stenting |
Patients presenting with symptoms such as fever, chills, flank pain, nausea, vomiting, burning micturition, and dysuria will be evaluated using standard imaging studies, including Ultrasound KUB or Computed Tomography (CT) KUB. The diagnosis of acute pyelonephritis will be confirmed based on the interpretation of imaging findings by a consultant urologist. Patients requiring early double J stenting will be enrolled in Group B (Double J Stenting). Criteria for early Double J stenting include persistent fever spikes, tachycardia, worsening abdominal tenderness, consistently elevated total leukocyte counts (TLC), pronounced pyuria, abnormal renal function (elevated serum creatinine), and ongoing hyponatremia. The intervention duration is within 24 to 48 hours, with stenting considered if these factors do not improve with medication during this period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of all genders above 18 years of age
2 All patients admitted with diagnosis of Acute Pyelonephritis.
3 Patients giving consent for taking part in the study.
|
|
| ExclusionCriteria |
| Details |
1 Patients with Pyonephrosis, Perinephric Abscess and Renal Abscess.
2 Pregnant females.
3 All patients with admitted with diagnosis of Emphysematous Pyelonephritis.
4 Patients who needed Percutaneous nephrostomy.
5 Patients who needed an external drainage of collection.
6 Patients who do not consent to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the factors determining the need for DJ stenting in patients with Acute Pyelonephritis. |
At baseline, at 24 hours, at 48 hours within the diagnosis of acute pyelonephritis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse the clinical profile of patients with Acute Pyelonephritis.
To analyse the predisposing factors associated in patients with Acute Pyelonephritis.
|
after one year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/01/2025 |
| 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)
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
|
Acute pyelonephritis (APN) is a severe, complicated urinary tract infection caused by the ascent of enteric bacteria, primarily Escherichia coli, from the bladder to the kidneys. It presents with systemic symptoms like fever, chills, and malaise, along with urinary symptoms such as frequency, urgency, and dysuria. Despite its global prevalence, particularly among women, and significant morbidity, epidemiological data on its incidence and causative organisms remain limited. The study aims to analyze factors determining the need for Double J (DJ) stenting in APN management and to evaluate the clinical profile and predisposing factors in these patients. Inclusion Criteria: Adults aged ≥18 years diagnosed with APN and consenting to participate.
Exclusion Criteria: Patients with pyonephrosis, perinephric/renal abscess, emphysematous pyelonephritis, requiring percutaneous nephrostomy or external drainage, or pregnant females. Data collection will include demographic details, comorbidities, urological history, clinical symptoms, and blood investigations (CBC, RFT, RBS, HbA1c, cultures). Monitoring will cover key parameters such as fever, tachycardia, and renal function from admission to discharge. The study will recruit patients over one year, with endpoints focusing on clinical and diagnostic factors predicting the need for DJ stenting. |