| CTRI Number |
CTRI/2026/02/104810 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study in burn patients to see whether measuring pressure inside the abdomen can help in early detection of kidney injury. |
|
Scientific Title of Study
|
Role of Intraabdominal pressure Monitoring in prediction of Acute Kidney Injury in Burns Patients-An observational Prospective Cohort 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 Esther Lalneidiki |
| Designation |
Junior Resident |
| Affiliation |
AIIMS,New Delhi |
| Address |
5th Floor,Academic Block,Department of Anaesthesiology Office,All India Institute of Medical Sciences, Ansari Nagar, New Delhi – 110029
South
DELHI
110029
India |
| Phone |
8732828658 |
| Fax |
|
| Email |
esseelpachuau@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surabhi Gupta |
| Designation |
Assistant Proffesor |
| Affiliation |
AIIMS,New Delhi |
| Address |
5th Floor,Academic Block,Office of Department ofAnaesthesiology,All India Institute of Medical Sciences, Ansari Nagar, New Delhi – 110029
South
DELHI
110029
India |
| Phone |
8076748659 |
| Fax |
|
| Email |
drsurabhi.anaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surabhi Gupta |
| Designation |
Assistant Proffesor |
| Affiliation |
AIIMS,New Delhi |
| Address |
5th Floor,Academic Block,Office of Department of Anaesthesiology,All India Institute of Medical Sciences, Ansari Nagar, New Delhi – 110029
South
DELHI
110029
India |
| Phone |
8076748659 |
| Fax |
|
| Email |
drsurabhi.anaesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi – 110029, India
|
|
|
Primary Sponsor
|
| Name |
AIIMS,New Delhi |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi – 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Esther Lalneidiki |
AIIMS,New Delhi |
Department of Anaesthesiology,Pain Medicine and Critical Care.
All India Institute of Medical Sciences, Ansari Nagar, New Delhi – 110029
South
DELHI |
8732828658
esseelpachuau@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18 to 60 years.
2. Thermal or scald burns involving 20–60% Total Body Surface Area (TBSA).
3. Admission to the Burn ICU within 48 hours of burn injury.
4. Presence of indwelling Foley’s catheter for urine output monitoring (as per standard care).
5. Provision of informed written consent by the patient or legally authorized representative.
|
|
| ExclusionCriteria |
| Details |
1. Pre-existing renal disease or history of chronic kidney disease (CKD) (baseline creatinine greater than 1.5 mg/dL or known abnormal renal ultrasound).
2. Pre-existing bladder pathology such as neurogenic bladder, vesicoureteral reflux, bladder outlet obstruction, or recent urological procedures.
3. Abdominal surgery within the past 7 days prior to enrollment.
4. Pregnant women.
5. Patients with electrical burns exceeding 60 percentage TBSA or associated crush injuries.
6. Patients who decline consent or withdraw participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Development of AKI as defined by KDIGO 2012 criteria during ICU stay.
|
Baseline and every 24 hours till Day 5 or ICU discharge, whichever is earlier.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Determine IAP threshold predicting AKI
|
At baseline and daily up to Day 5 or ICU discharge
|
Assess Abdominal perfusion pressure(APP) and Renal Replacement Therapy (RRT) requirement
|
Daily up to Day 5 or ICU discharge
|
Correlation between abdominal girth and IAP
|
Every 12 hours up to Day 5
|
IAP trends and fluid resuscitation
|
During first 5 days of ICU stay
|
Association of IAP with ICU outcomes (Length of stay,ventilation, mortality)
|
At ICU discharge or death
|
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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)
|
10/03/2026 |
| 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="2"
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
|
This is a prospective observational cohort study conducted in the Burns Intensive Care Unit of AIIMS New Delhi. The study aims to evaluate the role of intra abdominal pressure monitoring in the early prediction of acute kidney injury in adult burn patients. Acute kidney injury is a frequent and serious complication in major burns, and early detection is essential for improving outcomes. Intra abdominal pressure will be measured by the intravesical (bladder) method every 12 hours for five days or until ICU discharge. Renal function will be assessed daily using serum creatinine and urine output as per KDIGO 2012 criteria. The study will include adult patients aged 18 to 60 years with 20 to 60 percent total body surface area burns admitted within 48 hours of injury. Patients with pre existing chronic kidney disease, bladder pathology, recent abdominal surgery, pregnancy, or who decline consent will be excluded. Data will be analyzed to determine whether raised intra abdominal pressure predicts acute kidney injury, to identify threshold pressure values, and to evaluate associations with abdominal perfusion pressure, renal replacement therapy requirement, and clinical outcomes such as ICU length of stay, mechanical ventilation, and mortality. Findings may support integration of intra abdominal pressure monitoring into standard burn resuscitation protocols for early detection and prevention of renal complications.
|