| CTRI Number |
CTRI/2024/06/068910 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the utility of hematological parameters (platelets, lymphocytes, neutrophils) in predicting Acute Kidney Injury |
|
Scientific Title of Study
|
Assessing the utility of Platelet-to-Lymphocyte ratio and Neutrophil-to-Lymphocyte ratio as predictors of Acute Kidney Injury in ICU patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tenneti Venkata Jaya Divya |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8861955649 |
| Fax |
|
| Email |
divyatenneti1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar UK |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845163448 |
| Fax |
|
| Email |
shekar.uk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekar UK |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Hospital, Manipal
KARNATAKA
576104
India |
| Phone |
9845163448 |
| Fax |
|
| Email |
shekar.uk@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, 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 Tenneti Venkata Jaya Divya |
Kasturba Medical College, Manipal |
Department of General Medicine
Wards- ICU1, ICU2, ICU3
Udupi
KARNATAKA |
8861955649
divyatenneti1412@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-2 (Student 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 |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18 and above admitted to the Intensive Care Unit(ICU)
|
|
| ExclusionCriteria |
| Details |
1. Patients with a pre-existing diagnosis of chronic kidney disease
2. Pregnant patients
3. Patients who have had a second admission to the ICU
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Platelet-to-Lymphocyte Ratio (PLR) and Neutrophil-to-Lymphocyte Ratio (NLR) will be used as markers to predict Acute Kidney Injury (AKI) in patients admitted to the Intensive Care Unit (ICU). |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze & compare the baseline levels of Platelet-to-Lymphocyte Ratio (PLR) & Neutrophil-to-Lymphocyte Ratio (NLR) in patients with & without Acute Kidney Injury (AKI)
To evaluate & determine the optimal cut-off values & Sensitivity/ Specificity of PLR & NLR for predicting the development of AKI
Assess the prognostic value of PLR & NLR for in-hospital mortality |
2 years 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
11/07/2024 |
| 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 an observational cross-sectional study which aims to evaluate the potential utility of
Platelet-to-Lymphocyte Ratio (PLR) and Neutrophil-to-Lymphocyte Ratio (NLR) as
predictive markers for the occurrence of Acute Kidney Injury (AKI) in patients
admitted to the Intensive Care Unit (ICU). Information regarding the patients’ demographics including
age, gender, and comorbidities will be collected in a data proforma for
every patient admitted to ICU based on the inclusion and
exclusion criteria. Laboratory data including complete blood counts, renal
function and liver function tests, and serum C-Reactive Protein (CRP)
concentrations done at admission will be documented. The PLR will be defined as the ratio of the absolute platelet count to
the absolute lymphocyte count and NLR will be defined as the ratio of the absolute
neutrophil count to the absolute lymphocyte count. Severity-of-illness
scores, including the Simplified Acute Physiology Score II (SAPS II), and
Sequential Organ Failure Assessment (SOFA) score will be recorded for each patient at the time of admission to ICU. The diagnosis
of AKI will be made based on KDIGO (Kidney Disease: Improving Global Outcomes) criteria and the patients will be
subsequently stratified into two groups: a non-AKI and an AKI
group. All the patients admitted to the ICU will be followed
up for the clinical outcome. Only one admission of the patient during the study
period will be considered. The Clinical outcome will be assessed by: Development of
AKI, Duration of ICU stay in days. Use of inotropes, Use of ventilator, survived
or non-survived. As this study is purely observational, patient management will
be chosen by patients’ physician without any intervention from study
investigators. |