| CTRI Number |
CTRI/2025/05/087535 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Can Blood Tests Predict Kidney Damage in Sepsis? A Study on Platelet-Albumin Ratio and NGAL |
|
Scientific Title of Study
|
A Comparison of platelet to albumin ratio and serum Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in patients with sepsis: an 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 |
Aishwary Shivhare |
| Designation |
senior resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anesthesia and Critical Care Medicine, AIIMS Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9901887223 |
| Fax |
|
| Email |
aishwary2017shivhare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikhil Kothari |
| Designation |
professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anesthesia and Critical Care Medicine, AIIMS Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996948 |
| Fax |
|
| Email |
drnikhilkothari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwary Shivhare |
| Designation |
senior resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anesthesia and Critical Care Medicine, AIIMS Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9901887223 |
| Fax |
|
| Email |
aishwary2017shivhare@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS Jodhpur, rajasthan, pin 342005 |
| 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 Aishwary Shivhare |
AIIMS Jodhpur |
adult intensive care unit (AICU), 3rd floor, IPD building, department of anesthesia and critical care medicine, AIIMS Jodhpur, Rajasthan, pin-342005
Jodhpur
RAJASTHAN |
9901887223
aishwary2017shivhare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, AIIMSJodhpur |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1.Patients with sepsis
2.Age more than 18 years
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1.Multiple ICU admissions
2.Pre-existing renal disease
3.Missing data
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the role of PAR and serum NGAL in predicting AKI in patients with sepsis admitted to ICU |
At the time of admission (baseline) and at the time of development of acute kidney injury (AKI) according to KDIGO criteria |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To establish an optimum cut-off value for PAR & serum NGAL for diagnosing sepsis & to prognosticate the outcome of sepsis.
2. Evaluation of the combined value of PAR & NGAL for predicting the development of AKI in sepsis
|
1. At the time of admission (baseline)
2. Once the patient develops acute kidney injury (AKI) according to KDIGO criteria.
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/06/2025 |
| 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 Yet Recruiting |
| 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
|
My study, "A Comparison of Platelet-to-Albumin Ratio and Serum Neutrophil Gelatinase-Associated Lipocalin (NGAL)
to Predict AKI in Patients with Sepsis," An observational study will be carried
out in the Adult Intensive Care Unit of All India Institute of Medical Sciences, the study will include all patients of age >= 18 years with sepsis. Patients
with repeated ICU admission and pre-existing renal disease shall be excluded.
The research question is to find out whether PAR has a similar diagnostic and
prognostic value as serum NGAL to predict AKI.
The study aims to investigate the role of PAR and
urinary NGAL in predicting AKI in patients admitted to the ICU with sepsis. The
expected outcome is to define an optimum cut-off value of PAR and
serum NGAL for diagnosing sepsis & to prognosticate the outcome of sepsis,
which helps in the early identification of AKI and thus early intervention and
management. |