BridgeMD
New treatment option for Hepatic Encephalopathy
Official title A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis
ClinicalTrials.gov ID: NCT06808074
What this study is testing
What is Inhaled amikacin?
Inhaled amikacin is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for hepatic encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hyderabad, Telangana, India
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderabad, Telangana, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.