| CTRI Number |
CTRI/2026/02/104550 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of oxygenation in ICU patients with ARDS by inhaled Amikacin and its evaluation. |
|
Scientific Title of Study
|
Evaluation of effects on oxygenation in terms of PaO2/FiO2 ratio by inhaled Amikacin in critically ill ARDS patients:A Double blinded Quasi experimental study. |
| 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 Manoj Tripathi |
| Designation |
Professor (Junior grade) |
| Affiliation |
DR Ram Manohar Lohia Institute of medical sciences |
| Address |
Department of Anesthesiology and CCM,DR Ram Manohar Lohia Institute of Medical Sciences, Vibhuti khand, Gomti Nagar, Lucknow, India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7607286685 |
| Fax |
|
| Email |
georgian.manojt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Tripathi |
| Designation |
Professor (Junior grade) |
| Affiliation |
DR Ram Manohar Lohia Institute of medical sciences |
| Address |
Department of Anesthesiology and CCM,DR Ram Manohar Lohia Institute of Medical Sciences, Vibhuti khand, Gomti Nagar, Lucknow, India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7607286685 |
| Fax |
|
| Email |
georgian.manojt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdur Rehman Malik |
| Designation |
Resident |
| Affiliation |
DR Ram Manohar Lohia Institute of medical sciences |
| Address |
DR Ram Manohar Lohia Institute of Medical Sciences,Vibhuti khand, Gomti Nagar, Lucknow, India
DR RMLIMS, Vibhuti khand, Gomti Nagar, Lucknow, India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7409721959 |
| Fax |
|
| Email |
alexmercer390@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ram Manohar Lohia Institute Of Medical Sciences |
| Address |
Vibhuti Khand, Gomti Nagar, Lucknow, 226010 |
| 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 |
| Dr Manoj Tripathi |
Dr Ram Manohar Lohia Institute of medical sciences |
ICU of Department of Anaesthesiology Dr Ram Manohar lohia Institute of medical sciences
Lucknow
UTTAR PRADESH |
8176007049
georgian.manojt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee, Dr RML IMS Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Ready to give written consent by legally acceptable relative.
2. Diagnosis of moderate to severe ARDS (Global Definition of ARDS 2024).
3. Patient requiring oxygen therapy (NIV, Venturi mask, mechanical invasive ventilation). |
|
| ExclusionCriteria |
| Details |
1. Known allergy to aminoglycosides.
2. Severe obstructive lung disease.
3. Pregnant and lactating women.
4. Acute kidney injury or Chronic kidney disease.
5. If patients were receiving systemic aminoglycoside therapy.
6. Participation in other interventional trials. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improving Pao2/FiO2 ratio in terms of length of stay in ICU and 28 days mortality in critically ill patients with ARDS |
28 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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
|
This study is designed to evaluate the effects of oxygenation in terms of PaO2/FiO2 ratio by inhaled Amikacin in critically ill ARDS patients. The inhaled root is a common means of administering bronchodilators and corticosteroids in patients suffering from chronic obstructive pulmonary disease or asthma, administration of inhaled antibiotics remains confidential. In an ICU, patients are specifically are at risk of nosocomial infections, and upto 40 % of critically ill patients develop ventilator associated pneumonia ( VAP ), which induces a prolonged ICU stay and potentially increases mortality. Inhaled antibiotic therapy enables delivery of very high antibiotic concentrations to the tracheobronchial tree, lung parenchyma, and tracheal tube biofilm. The efficacy of Inhaled antibiotics showed lower systemic toxicity, reduced emergence of bacterial resistance and enhanced activity against resistant bacteria. Amikacin exhibits a concentration dependent effects justifying the use of high doses to enhance the efficacy, however limited by its ototoxicity and nephrotoxicity. |