NCT06808074

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

February 12, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

January 29, 2025

Last Update Submit

April 3, 2025

Conditions

Hepatic EncephalopathyCirrhosisVentilator Associated Pneumonia (VAP)

Keywords

Inhaled amikacinProphylaxisVentilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Ventilator associated pneumonia

    At day 7 and day 28

Secondary Outcomes (5)

  • All-cause in-hospital mortality

    Day 28

  • Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)

    Day 7, 14, 28

  • Time to resolution of Hepatic encephalopathy

    Day 7, 14, 28

  • No. of ventilator free ICU days

    Day 28

  • Incidence of Acute kidney injury

    Day 7, 14, 28

Study Arms (2)

Inhaled Amikacin

EXPERIMENTAL
Drug: Inhaled amikacin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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.

Inhaled Amikacin
PlaceboDRUG

The equivalent volume of saline solution (0.9% sodium chloride \[NaCl\]) will be administered once daily for three consecutive days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

  • Patients with Chronic kidney disease on maintenance hemodialysis
  • Pregnancy or breast-feeding.
  • Patients known to be allergic to aminoglycosides.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AIG Hospitals

Hyderabad, Telangana, 500032, India

RECRUITING

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500032, India

RECRUITING

MeSH Terms

Conditions

Hepatic EncephalopathyFibrosisPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHealthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease Attributes

Central Study Contacts

Anand V Kulkarni

CONTACT

+ 8553322434anandvk90@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Department of Hepatology

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 5, 2025

Study Start

February 12, 2025

Primary Completion

February 1, 2026

Study Completion

May 1, 2026

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)