| CTRI Number |
CTRI/2025/02/080406 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Diaphragm Ultrasound in ARDS for evaluating the advantage of Theophylline and anti-oxidant |
|
Scientific Title of Study
|
Diaphragm Ultrasound to evaluate therapeutic effect of theophylline and anti-oxidant in ARDS - A Randomized Controlled Study |
| Trial Acronym |
DUTTAARDS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Akhilesh |
| Designation |
Post graduate |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
H No 2-4-995
Road no 3A
Samathapuri Colony
Nagole
Hyderabad
Hyderabad
TELANGANA
500035
India |
| Phone |
7799548485 |
| Fax |
|
| Email |
akhil24.thewall@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Akhilesh |
| Designation |
post graduate |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
H No 2-4-995
Road no 3A
Samathapuri Colony
Nagole
Hyderabad
Hyderabad
TELANGANA
500035
India |
| Phone |
7799548485 |
| Fax |
|
| Email |
akhil24.thewall@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Akhilesh |
| Designation |
post graduate |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
H No 2-4-995
Road no 3A
Samathapuri Colony
Nagole
Hyderabad
Hyderabad
TELANGANA
500035
India |
| Phone |
7799548485 |
| Fax |
|
| Email |
akhil24.thewall@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Punjagutta
Hyderabad
Pin 500082 |
| 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 |
| Akhilesh M |
ICU |
Nims Hospital
Hyderabad
TELANGANA |
7799548485
akhil24.thewall@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard treatment of ARDS |
1. Steroids
2. Supportive ventilation
3. Treatment of the underlying cause
4. Supportive treatment
5. Positional change (Prone) |
| Intervention |
Theophylline and Vitamin-E |
Patients with mild-moderate ARDS grouped into ‘Experimental groups’ will receive Theophylline 3-6 mg/kg oral and Vitamin-E 400 I.U/ day after informed consent, apart from the standard treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical History and investigations that support diagnosis of mild-moderate ARDS |
|
| ExclusionCriteria |
| Details |
1. Severe ARDS
2. MODS
3. Pregnancy
4. Severe traumatic brain injury
5. Phrenic nerve injury
6. Hepatic dysfunction
7. Abdominal Surgeries
8. Renal failure on RRT
9.Long term use of Steroids |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of the combination of theophylline and antioxidants as adjunctive therapy with the standard treatment in the outcome of mild-moderate ARDS patients by serial ultrasound imaging of diaphragm. |
Day 1,2,3,4,5,6,7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine the length of ICU stay |
Day 1,2,3,4,5 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="24"
Months="8"
Days="24" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
with mild-moderate ARDS grouped into ‘Experimental groups’ will receive
Theophylline 3-6 mg/kg oral and Vitamin-E 400 I.U/ day after informed consent,
apart from the standard treatment. While,
the ‘Control group’ won’t receive Theophylline and vitamin-E. Through
monitoring of HR, BP, ECG, SpO2, FiO2, ventilator settings(if any), and urine output will be done. Sonographic
examination of the bilateral hemidiaphragm includes measurement of muscle size
to evaluate for potential atrophy, analysis of muscle contraction, and
thickening ratios at maximum inspiration and end-expiration. Pertinent findings
such as the presence of pleural effusions, ascites or hepatomegaly should be
reported. |