| CTRI Number |
CTRI/2024/12/077810 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of B-Type Natriuretic Peptide in predicting in Hospital mortality and Length of stay of Acute Exacerbation of Chronic Obstructive Pulmonary Disease Cases with Normal Heart function |
|
Scientific Title of Study
|
Predictive Value of B-Type Natriuretic Peptide in Outcome of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Preserved Left
Ventricular Function
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRavi Prakash Yadav |
| Designation |
Senior Resident |
| Affiliation |
IGIMS |
| Address |
Department of Critical Care Medicine, IGIMS,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
9453197582 |
| Fax |
|
| Email |
ravipyadav1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
Head of Department |
| Affiliation |
IGIMS |
| Address |
Department of Critical Care Medicine, IGIMS,Sheikhpura,Patna
Patna
BIHAR
800014
India |
| Phone |
9473191829 |
| Fax |
|
| Email |
Sanjeev_pranay71@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRavi Prakash Yadav |
| Designation |
Senior Resident |
| Affiliation |
IGIMS |
| Address |
Department of Critical Care Medicine, IGIMS,Sheikhpura,Patna
BIHAR
800014
India |
| Phone |
9453197582 |
| Fax |
|
| Email |
ravipyadav1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical Care Medicine IGIMS ,Patna 800014, Bihar,INDIA |
|
|
Primary Sponsor
|
| Name |
Department of Critical Care Medicine |
| Address |
IGIMS,Sheikhpura,Patna,Bihar 800014 |
| 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 |
| DrRavi Prakash Yadav |
IGIMS ,Patna |
Critical Care Medicine ICU
IGIMS Sheikhpura Patna
Patna
BIHAR |
9453197582
ravipyadav1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,IGIMS,Sheikhpura,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of COPD with acute exacerbation |
|
| ExclusionCriteria |
| Details |
Known cases of cardiovascular disease, other chronic
respiratory diseases such as asthma, interstitial lung diseaseand other chronic diseases like chronic kidney or liver diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need of ventilation (Non invasive ,Invasive) in Different BNP groups. |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of Hospital stay and mortality in different BNP groups. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/12/2024 |
| 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="1"
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
|
In COPD cases exacerbation may be due to Infection or part of underlying Heart failure, that is not evident on early ECHO finding of Ejection Fraction that may be Normal but by Molecular testing of Heart Failure by BNP we will predict earlier the part of Heart failure in exacerbation and requiring long stay in hospital and also relation with mortality.
|