| CTRI Number |
CTRI/2025/11/097404 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalence of sepsis-associated acute kidney injury and its association with abdominal adipose tissue among patients with Sepsis. |
|
Scientific Title of Study
|
Prevalence and association between acute kidney injury and central obesity among patients with sepsis admitted to the critical care units of a tertiary care hospital in Udupi, Karnataka. |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sweekrity Benjamin |
| Designation |
Nurse Practitioner in Critical Care |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
09123155956 |
| Fax |
|
| Email |
sweekrity.mconmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Janet Prameela Dsouza |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Department of Medical Surgical Nursing,1st floor, Manipal College of Nursing, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9986417306 |
| Fax |
|
| Email |
janet.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Janet Prameela Dsouza |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Department of Medical Surgical Nursing,1st floor, Manipal College of Nursing, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9986417306 |
| Fax |
|
| Email |
janet.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal |
| Address |
Kasturba Hospital Manipal Karnataka India 576104 |
| 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 Souvik Chaudhuri |
Kasturba Hospital Manipal |
ICU1 and ICU2 of Kasturba Hospital, Manipal, karnataka.
Udupi
KARNATAKA |
9937178620
souvik.chaudhuri@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional committee 2(student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N17||Acute kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged above 18 years,
2 Patients of sepsis as diagnosed by the SOFA score based on Sepsis 3 criteria and having AKI based on KDIGO guideline criteria (SA-AKI).
3 Admitted or transferred to ICUs
|
|
| ExclusionCriteria |
| Details |
1 Patients with a previously diagnosed chronic kidney disease (CKD) of any stage.
2 Patients presenting with acute kidney injury (AKI) of more than 2 days’ duration (acute kidney disease, AKD), as the cause of AKD will be difficult to ascertain due to limitations in prospective follow-up.
3 Discharge/death/transfer before 24 hrs of ICU admission.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prevalence of acute kidney injury in sepsis patients
2. Proportion of patients with AKI developing non-resolving AKI and AKD.
3. Association between central obesity and development of AKI
|
Presence or absence of AKI - At baseline (during admission to the hospital)
If AKI is absent - assessment for development of AKI on 1st day of ICU admission, 3rd, and 5th day
Assessment for central obesity - 1st day of ICU admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
10/12/2025 |
| 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="0"
Months="10"
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
|
About 20% of patients admitted to the ICUs have
obesity. Obesity, apart from its well-known cardio-vascular and metabolic
adverse effects, also potentiates cytokine release, leading to a low-grade
inflammatory state. Obesity has been associated with a higher risk of early
SA-AKI, and studies have shown an association between obesity and the
development of acute kidney injury (AKI) in patients with critical illness.
Though obesity is known to be a risk factor for AKI and CKD, whether it
specifically causes SA-AKI has not been extensively studied. Traditionally, the
classification of obesity has been based on BMI. However, it is difficult to
measure BMI in critically ill ICU patients to determine obesity class, as
equipment to measure the weights in supine patients is often unavailable in
resource-limited settings.The purpose of the study is to determine if central obesity (as assessed by B-mode ultrasound of intra-abdominal fat thickness and pre-peritoneal fat thickness) is associated with AKI in patients with sepsis. Investigating this association could reveal potential biomarkers or therapeutic targets to enhance patient outcomes in a critical care environment. |