| CTRI Number |
CTRI/2024/07/071197 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF KETAMINE NEBULIZATION IN ACUTE RESPIRATORY DISTRESS SYNDROME |
|
Scientific Title of Study
|
THERAPEUTIC EFFECT OF KETAMINE NEBULIZATION IN ACUTE RESPIRATORY DISTRESS SYNDROME: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMNA KHATOON |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Anaesthesiology and Critical care, Near gate no. 2, King George Medical University, Lucknow
Department of Anaesthesiology, KGMU
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8191925464 |
| Fax |
|
| Email |
KIRANZEHRA01@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
RAVI PRAKASH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY, LUCKNOW |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KING GEORGE MEDICAL UNIVERSITY, CHOWK, LUCKNOW, UTTAR PRADESH
DEPARTMENT OF ANAESTHESIA, KGMU
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450610553 |
| Fax |
|
| Email |
drraviprakash94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
AMNA KHATOON |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KING GEORGE MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Anaesthesiology and Critical care, King George Medical University, Lucknow
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, KGMU
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8191925464 |
| Fax |
|
| Email |
KIRANZEHRA01@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| King George Medical University, Lucknow |
|
|
Primary Sponsor
|
| Name |
King George Medical University |
| Address |
Chowk, Lucknow, 226003, Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| AMNA KHATOON |
KING GEORGE MEDICAL UNIVERSITY, LUCKNOW |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, NEAR GATE NO. 2, CHOWK, LUCKNOW
Lucknow
UTTAR PRADESH |
08191925464
KIRANZEHRA01@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KING GEORGE MEDICAL UNIVERSITY, LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy in Acute respiratory distress syndrome patients. |
Group C will receive Conventional therapy with nebulization with 5 ml normal saline 3 times a day in addition to standard treatment of ARDS.
The following parameters will be recorded :
Demographic data.
APACHE Score at the time of admission. Daily SOFA score.
Daily P/F ratio.
Murray Score.
IL-6 level on Day 1,3 and 5. 28 days mortality.
Sedative requirement
Pregnant women
Patient/Attendant not giving consent
Vasopressor requirement(if any)
END POINT OF STUDY
Patient will receive conventional therapy uptill - Maximum for 5 days,
Or PaO2/FiO2 ≥300,
Or patient expires. |
| Intervention |
Ketamine nebulization in Acute Respiratory Distress Syndrome patients. |
Group K will be treated with 0.75 mg/kg ketamine (diluted in normal saline to make volume of 5 ml) nebulization 3 times a day in addition to standard treatment of ARDS
The following parameters will be recorded :
Demographic data.
APACHE Score at the time of admission. Daily SOFA score.
Daily P/F ratio.
Murray Score.
IL-6 level on Day 1,3 and 5. 28 days mortality.
Sedative requirement
Pregnant women
Patient/Attendant not giving consent
Vasopressor requirement(if any)
END POINT OF STUDY
Patient will receive therapy uptill - Maximum for 5 days,
Or PaO2/FiO2 ≥300,
Or patient expires |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age 20-50 years
Mechanically ventilated adult patients admitted to the
ICU with developing ARDS. |
|
| ExclusionCriteria |
| Details |
Pregnant women
Patient/Attendant not giving consent
Underlying cardiac, and neurological disorders
Previous history of psychiatric disorder / substance abuse APACHE Score ≥25
Patient expiring within 3 days of initiation of therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the therapeutic effect of ketamine nebulization in ARDS based on Murray Score. |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of ketamine nebulization on IL-6 levels in ARDS patients on Day 1, 3 & 5. |
5 days |
| To evaluate effect of ketamine nebulization on 28 days mortality in ARDS patients |
28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Kiranzehra01@gmail.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 31-07-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The aim of study is to estimate the effect of ketamine nebulization in Acute Respiratory Distress Syndrome (ARDS). In this study, 20-50 years old, mechanically ventilated adult patients admitted to the ICU with diagnosis of ARDS (based on Berlin’s criteria) would be included. The patients will be divided into two groups- 1. Group K will be treated with 0.75 mg/kg ketamine (diluted in normal saline to make volume of 5 ml) nebulization 3 times a day in addition to standard treatment of ARDS 2. Group C will receive Conventional therapy with nebulization with 5 ml normal saline 3 times a day in addition to standard treatment of ARDS. The following parameters will be recorded : - Demographic data; APACHE Score at the time of admission; Daily SOFA sco; Daily P/F ratio; Murray Score; IL-6 level on Day 1,3 and 5; 28 days mortality; Sedative requirement; Vasopressor requirement(if any). Patient will receive therapy uptill - Maximum for 5 days,Or PaO2/FiO2 ≥300, Or patient expires.
|