| CTRI Number |
CTRI/2024/03/063588 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Importance of white cell, platelet cell ratio in long standing obstructive lung disease |
|
Scientific Title of Study
|
The significance of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in patients with 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 |
Dr Satya Roy |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of general medicine, 2nd floor opd block, Kasturba Medical college, manipal, tiger circle, Madhav nagar, Udupi 576104 Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9006805672 |
| Fax |
|
| Email |
medicosatyaroy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar U K |
| Designation |
Professor and HOU |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of general medicine, 2nd floor opd block, Kasturba Medical college, manipal, tiger circle, Madhav nagar, Udupi 576104 Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9845163448 |
| Fax |
|
| Email |
shekar.uk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mounika Ch |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of general medicine, 2nd floor opd block, Kasturba Medical college, manipal, tiger circle, Madhav nagar, Udupi 576104 Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
783957169 |
| Fax |
|
| Email |
mounika.cherukuri@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal
|
|
|
Primary Sponsor
|
| Name |
Dr Satya Roy |
| Address |
Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Satya Roy |
Kasturba hospital manipal |
Department of general medicine second floor, OPD block, Kasturba medical college KMC manipal, Udupi Karnataka 576104
Udupi
KARNATAKA |
9006805672
medicosatyaroy@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: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil since it’s an observational study |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
CASES-
1) Patients with diagnosis of acute exacerbation of COPD defined as acute worsening of respiratory symptoms such as breathlessness, cough with sputum severe enough requiring hospital admission
CONTROLS-
1) Clinically stable COPD patients diagnosed on the basis of GOLD guidelines admitted for other reasons in the medical ward or from the medicine and pulmonary medicine outpatient clinic will be taken as controls |
|
| ExclusionCriteria |
| Details |
1)Patients with bronchial asthma
2)Patients with bronchiectasis
3)Pulmonary tuberculosis patients
4)Patients on oral steroid treatment
5) Patients with other infective conditions- UTI, sepsis due to other causes etc
6)Patients with other inflammatory conditions-inflammatory arthritis, inflammatory bowel disease
7)Patients with autoimmune conditions- SLE etc
8)Patients with hematological disorders
9)Patients with malignancies
10)Patients with a recent MI/stroke |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate NLR PLR, Procalcitonin, CRP, clinical outcome |
at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="242"
Sample Size from India="242"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="121" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
31/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
At present, there have been few articles with varying results on the association of neutrophil to lymphocyte (NLR) ratio and platelet to lymphocyte (PLR) ratio in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) compared to stable COPD patients. NLR and PLR are easily accessible and inexpensive markers that have the potential to assist in the risk stratification of hospitalized AECOPD patients, particularly in resource-limited settings, and improve patient outcomes with timely intervention. Several studies have shown that NLR levels were higher in patients with AECOPD than in stable-state COPD patients, implying that NLR levels can be used as a marker of acute exacerbation. Levels of PLR were also found to be significantly higher in patients who required mechanical ventilation. It was also seen that mean levels of NLR and PLR among patients admitted to ICU were significantly higher among non-survivors compared to survivors of AECOPD. The combination of NLR, PLR, and CRP have been shown to increase the prognostic sensitivity. It has been concluded that NLR may be an easily available and inexpensive marker for mortality in patients with AECOPD. |