| CTRI Number |
CTRI/2022/07/044036 [Registered on: 15/07/2022] Trial Registered Prospectively |
| Last Modified On: |
14/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The utility and side effects of Aminophylline in COPD patients |
|
Scientific Title of Study
|
Aminophylline in treatment of acute exacerbation of COPD : ACUTE study(Aminophylline in COPD- utility and Treatment effects)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrita Bhattacharyya |
| Designation |
Head , Respiratory Intensive Care Unit |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
The Calcutta Medical Research Institute,
Respiratory Intensive Care Unit(RICU)
Level 4
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027, West Bengal
Kolkata
WEST BENGAL
Kolkata 700027
India |
| Phone |
03340904090 |
| Fax |
|
| Email |
pupuldoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrita Bhattacharyya |
| Designation |
Head , Respiratory Intensive Care Unit |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
The Calcutta Medical Research Institute,
Respiratory Intensive Care Unit(RICU)
Level 4
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027, West Bengal
Kolkata
WEST BENGAL
Kolkata 700027
India |
| Phone |
9919645454 |
| Fax |
|
| Email |
pupuldoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Bhattacharyya |
| Designation |
Head , Respiratory Intensive Care Unit |
| Affiliation |
The Calcutta Medical Research Institute |
| Address |
The Calcutta Medical Research Institute,
Respiratory Intensive Care Unit(RICU)
Level 4
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027, West Bengal
Kolkata
WEST BENGAL
Kolkata 700027
India |
| Phone |
9919645454 |
| Fax |
|
| Email |
pupuldoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Medical Research Institute |
|
|
Primary Sponsor
|
| Name |
The Calcutta Medical Research Institute |
| Address |
7/2 Diamond Harbour Road,Kolkata-700027 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Amrita Bhattacharyya |
The Calcutta Medical Research Institute |
Respiratory Intensive Care Unit(RICU), Level 4
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road
Kolkata-700027
Kolkata
WEST BENGAL |
9919645454
pupuldoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteeTheCalcutta Medical Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, (2) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV Aminophylline
|
Slow iv loading dose of 6 mg per kg( maximum of 25 mg per minute )
Maintainance dose of .5 mg per kg per hour over 24 hours
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient of documented COPD as per GOLD guidelines, admitted with COPD exacerbation.
Persistent hypoxia with PF ratio<200 AND hypercarbia with pCO2>45 ±respiratory acidosis despite maximal standard therapy for COPD exacerbation 72 hours post hospitalisation |
|
| ExclusionCriteria |
| Details |
Known structural or physiological cardiac co morbidity
-Any other systemic co morbidity that is known to worsen with aminophylline
-Persistent Tachycardia(Heart rate>100/min) with or without rate limiting drugs, wherever indicated.
-If patient is on any drug known to interact with aminophylline
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Length of hospital stay
Length of ICU stay
ABG changes in Oxygenation- PF
ratio
ABG changes in pCO2 levels
|
Length of hospital stay
Length of ICU stay
ABG changes in Oxygenation-
ABG changes in pCO2 levels
AT 24 AND 48 HOURS AFTER DRUG INITIATION
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dyspnoea: modified Borg Scale
2. Mortality
|
Discharge day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/07/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The main Objective of the study is to assess safety, tolerability and clinical
effects of aminophylline infusion in treatment of acute exacerbation of COPD
.
We intend to screen all patients presenting to our respiratory ICU with
labelled COPD in an exacerbation ( as defined by GOLD) for inclusion into our
study for a period of 1 year from
15.7.2022 .All of these patients will be managed conventionally with
standard therapy for COPD by an independent group of treating physicians. Post
72 hours, the patients will be reassessed and all patients fitting the
inclusion criteria will be administered aminophylline .All patients being
administered aminophylline will be subject to continuous ECG monitoring and 6
hourly abg analysis in the 24 hour period of aminophylline administration. Atleast
another arterial blood gas analysis will be done at the end of 48 hours of
initiation of aminophylline infusion. Dyspnoea as measured by the modified BORG
scale will be evaluated by an independent respiratory therapist.
Aminophylline
is an old and inexpensive drug which is known for its pleotropic action and
synergism with inhaled bronchodilators. It has fallen into disfavour due to its
pronounced adverse effects. We believe when administered to the right sub group
of patients the benefits far out weigh the risks, and it may prove a worthy
salvage option for critically ill patients.
|