Hepatic EncephalopathyPhase 4NCT06808074
A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis
A Phase 4 study testing Inhaled amikacin in people with Hepatic Encephalopathy and Cirrhosis, run by Asian Institute of Gastroenterology, India at 2 sites in India.
Trial summary
The recent AMIKINHAL trial found 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis, Ventilator Associated Pneumonia (VAP)
- What is being tested?
- Inhaled amikacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 2 sitesIndia
- Study dates
- 12 Feb 2025to May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.
- Patient is aged ≥18 years.
- Written informed consent of the patient or a proxy.
Who cannot join
- Suspected or confirmed Pneumonia at the day of inclusion.
- Patients with Chronic kidney disease on maintenance hemodialysis
- 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
- Pregnancy or breast-feeding.
- Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.
- Patients known to be allergic to aminoglycosides.
- Patients who received intravenous Amikacin before 7 days of inclusion in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
AIG Hospitals
Hyderabad, Telangana, 500032
Kulkarni, +918553322434, anandvk90@gmail.com
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500032
Anand V Kulkarni, + 8553322434, anandvk90@gmail.com
About this study
Official title: Inhaled Amikacin as a Prophylaxis for Ventilator Associated Pneumonia in Patients With Cirrhosis: A Randomized Placebo Controlled Double Blind Study
The recent AMIKINHAL trial found 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 physicians. Due to the lack of randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE, conducting this study is necessary to evaluate the efficacy of inhaled amikacin. The study results may provide evidence -based guidance for therapy in this patient population.
- Being tested
- Inhaled amikacin, Placebo
- Keywords
- Inhaled amikacin, Prophylaxis, Ventilator associated pneumonia
- Medical subject headings
- Hepatic Encephalopathy, Fibrosis, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled amikacinDrug
Dosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days.
PlaceboDrug
The equivalent volume of saline solution (0.9% sodium chloride [NaCl]) will be administered once daily for three consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Amikacin | Experimental | Not described Receives: Drug: Inhaled amikacin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventilator associated pneumonia
Measured: At day 7 and day 28
Secondary outcomes (5)
All-cause in-hospital mortality
Measured: Day 28
Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)
Measured: Day 7, 14, 28
Time to resolution of Hepatic encephalopathy
Measured: Day 7, 14, 28
No. of ventilator free ICU days
Measured: Day 28
Incidence of Acute kidney injury
Measured: Day 7, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start12 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Kulkarni, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808074
- Sponsor's protocol ID
- AIG/IEC-BH&R 62/09.2024-04
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Amikacin as a Prophylaxis for Ventilator Associated Pneumonia in Patients With Cirrhosis: A Randomized Placebo Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT06808074
- Acronym / sponsor ID
- AIG/IEC-BH&R 62/09.2024-04
- Keywords
- Inhaled amikacin, Prophylaxis, Ventilator associated pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The recent AMIKINHAL trial found 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 physicians. Due to the lack of randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE, conducting this study is necessary to evaluate the efficacy of inhaled amikacin. The study results may provide evidence -based guidance for therapy in this patient population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Amikacin | Experimental | Drug: Inhaled amikacin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.
- Patient is aged ≥18 years.
- Written informed consent of the patient or a proxy.
Key exclusion criteria (7 listed)
- Suspected or confirmed Pneumonia at the day of inclusion.
- Patients with Chronic kidney disease on maintenance hemodialysis
- 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
- Pregnancy or breast-feeding.
- Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled amikacinDosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days. | Drug | Inhaled Amikacin |
| PlaceboThe equivalent volume of saline solution (0.9% sodium chloride [NaCl]) will be administered once daily for three consecutive days | Drug | Placebo |
Primary outcome
Incidence of Ventilator associated pneumonia
Time frame: At day 7 and day 28
5 secondary outcomes
All-cause in-hospital mortality
Time frame: Day 28
Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)
Time frame: Day 7, 14, 28
Time to resolution of Hepatic encephalopathy
Time frame: Day 7, 14, 28
No. of ventilator free ICU days
Time frame: Day 28
Incidence of Acute kidney injury
Time frame: Day 7, 14, 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhaled amikacin in people with Hepatic Encephalopathy and Cirrhosis, run by Asian Institute of Gastroenterology, India at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anand V Kulkarni (+ 8553322434, anandvk90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ventilator associated pneumonia (time frame: At day 7 and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.