| CTRI Number |
CTRI/2024/12/078033 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the role of inhaled antibiotic Amikacin in preventing respiratory infections in patients with liver disease |
|
Scientific Title of Study
|
Inhaled Amikacin as a prophylaxis for Ventilator associated pneumonia in patients with cirrhosis: A Randomized placebo controlled double blind 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 Anand V Kulkarni |
| Designation |
Senior consultant |
| Affiliation |
AIG Hospitals |
| Address |
1-66/AIG/2 to 5, Cluster M, Hepatology Department, Room no 02, Asian Institute of Gastroenterology Hospitals, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad.
Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
08553322434 |
| Fax |
|
| Email |
anandvk90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand V Kulkarni |
| Designation |
Senior consultant |
| Affiliation |
AIG Hospitals |
| Address |
1-66/AIG/2 to 5, Cluster M, Hepatology Department, Room no 02, Asian Institute of Gastroenterology Hospitals, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad.
Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
08553322434 |
| Fax |
|
| Email |
anandvk90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand V Kulkarni |
| Designation |
Senior consultant |
| Affiliation |
AIG Hospitals |
| Address |
1-66/AIG/2 to 5, Cluster M, Hepatology Department, Room no 02, Asian Institute of Gastroenterology Hospitals, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad.
Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
08553322434 |
| Fax |
|
| Email |
anandvk90@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIG hospitals, Gachibowli, Hyderabad - Infrastructural support |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Anand V Kulkarni |
AIG hospitals |
1-66/AIG/2 to 5, Cluster M, Hepatology Department, Room no 02, Asian Institute of Gastroenterology Hospitals, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana 500032.
Hyderabad
Hyderabad
TELANGANA |
8553322434
anandvk90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ASIAN INSTITUTE OF GASTROENTEROLOGY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amikacin |
20MG/KG/day of amikacin will be administered as nebulization for 3 consecutive days after inclusion. |
| Comparator Agent |
Normal saline (Placebo) |
Equal volume of normal saline will be nebulized. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted with liver disease to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia. |
|
| ExclusionCriteria |
| Details |
a.Suspected or confirmed Pneumonia at the day of inclusion.
b.Patients with Chronic kidney disease on maintenance hemodialysis
c.Stage 2 or 3 Kidney Disease Improving Global Outcome (KDIGO) classification AKI the day of inclusion. Patients undergoing renal replacement therapy or for whom decision has been made to initiate renal replacement therapy can be included whatever the KDIGO stage
d. Pregnancy or breast-feeding.
e.Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.
f.Patients known to be allergic to aminoglycosides.
g. Patients who received intravenous Amikacin before 7 days of inclusion in this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Ventilator associated pneumonia |
Day 4, 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All-cause in-hospital mortality |
At day 28 |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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 4 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| 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="4"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
With the recent AMIKINHAL trial finding that prophylactic inhaled amikacin was effective in lowering the incidence of ventilator-associated pneumonia in ICU patients. Since aspiration is a common complication of cirrhosis patients with HE (7 out of 10 patients develop some type of HE) who are hospitalized to the liver ICU also have an elevated risk of Ventilator associated pneumonia. Despite supportive care and appropriate antimicrobial therapy pneumonia is linked to greater mortality in cirrhosis. This poses a significant challenge to the physicians. No randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE have been done. Therefore, Our investigation is necessary to evaluate the efficacy of inhaled amikacin to prevent VAP in cirrhosis patients with HE. The results of this study can help physicians choose therapies that are supported by evidence.
|