| CTRI Number |
CTRI/2025/06/089470 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
THE ROLE OF NEUTROPHIL TO LYMPHOCYTE RATION ,PLATELET TO LYMPHOCYTE RATIO, SERUM LACTATE IN EXACERBATION OF COPD |
|
Scientific Title of Study
|
Neutrophil to lymphocyte Ratio, Platelet to lymphocyte ratio and serum lactate as
prognostic indicators in patients with acute exacerbations of chronic obstructive pulmonary
disease. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital And Medical College Manipal |
| Address |
Department of respiratory medicine. Kasturba medical college . Manipal. MAHE .576104
Udupi
KARNATAKA
576104
India |
| Phone |
7988753275 |
| Fax |
|
| Email |
sheetalsharma09101997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Aswini kumar Mohapatra |
| Designation |
Head of Unit |
| Affiliation |
Kasturba Hospital And Medical College Manipal |
| Address |
Department of respiratory medicine. Kasturba medical college . Manipal. MAHE .576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845297200 |
| Fax |
|
| Email |
aswini.mohapatra@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sheetal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital And Medical College Manipal |
| Address |
Department of respiratory medicine. Kasturba medical college . Manipal. MAHE .576104
Udupi
KARNATAKA
576104
India |
| Phone |
7988753275 |
| Fax |
|
| Email |
sheetalsharma09101997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of respiratory medicine |
| Address |
Department of Respiratory medicine. Kasturba medical college . Manipal MAHE .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 Sheetal |
Kasturba Hospital |
Department of respiratory medicine. Kasturba medical college . Manipal. MAHE .576104
Udupi
KARNATAKA |
07988753275
sheetalsharma09101997@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 Students Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J980||Diseases of bronchus, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18 years of age
All patients who are diagnosed case of COPD |
|
| ExclusionCriteria |
| Details |
Patient diagnosed with Bronchial Asthma
Patient Diagnosed with Bronchiectasis
Patient Diagnosed with Active pulmonary Tuberculosis
Patient diagnosed with Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess the prognostic value of NLR in predicting in-hospital mortality in patients with
acute exacerbation of COPD
2) To assess prognostic value of PLR in predicting in-hospital mortality in patients with acute
exacerbation of COPD
3) To assess the prognostic value of lactate levels in predicting in-hospital mortality in
patients with acute exacerbation of COPD |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To analyze the association between Neutrophil to Lymphocyte Ratio (NLR) and
specific clinical outcomes, such as the duration of hospital stay, need for intensive
care unit (ICU) admission, & mortality in patients with acute exacerbation of
Chronic Obstructive Pulmonary Disease (COPD).
2) To analyze the association between Platelet to Lymphocyte Ratio (PLR) and
secondary outcomes, including the duration of hospitalization, ICU admission, and
mortality in individuals experiencing acute exacerbation of COPD.
3) To analyze the association between serum lactate levels & additional clinical
parameters, such as the length of hospital stay, ICU admission, & mortality, in
patients with acute exacerbation of COPD. |
9 months |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
05/07/2025 |
| 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="6"
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
|
Patients admitted with the diagnosis of AECOPD satisfying inclusion and exclusion criteria during the study period will be included, socio socio- demographic and clinical data of patients will be collected and recorded in case proforma upon admission. Details of comorbidities will be obtained from clinical notes. Breathlessness will be graded according to the modified Medical Research Council dyspnea (MMRC) score and patients will be divided in based on group A, B, E. History of smoking, Occupational exposure to smoke, Family History of COPD will be obtained. Routine investigations like CBC, ABG, chest radiograph at the time of admission will be done as a standard of care and results shall be recorded in the case proforma. The patient will be followed up during the entire hospital stay. Clinical Outcomes will be categorized as ICU admission, duration of admission, mortality. Later the NLR, PLR and serum lactate levels at the time of admission will be correlated with the clinical outcome of the patient. Lactate level blood (ABG) test will be considered as a standard care of test in patient of acute Exacerbation of COPD |