NCT07072572

Brief Summary

To guide the administration of intravenous albumin by lung ultrasound in decompensated cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

April 20, 2025

Last Update Submit

July 16, 2025

Conditions

CirrhosisCirrhosis AdvancedAcute Kidney InjuryAscites

Keywords

AlbuminLung ultrasound

Outcome Measures

Primary Outcomes (1)

  • Overall mortality at 30 days

    Overall mortality at 30 days

    30 days

Secondary Outcomes (6)

  • Respiratory failure

    Every 24 hours, during hospitalization, (assesed up to 28 days)

  • Acute kidney injury

    Every 24 hours, during hospitalization, (assesed up to 28 days)

  • Resolution of SBP

    Day three of antibiotic treatment initiated for spontaneous bacterial peritonitis.

  • Development of variceal hemorrhage

    During hospitailization, (assesed up to 28 days)

  • acute-on-chronic liver failure

    During hospitailization, (assesed up to 28 days)

  • +1 more secondary outcomes

Study Arms (2)

Conventional albumin group

NO INTERVENTION

Conventional albumin group

Lung ultrasound guided albumin administration group

EXPERIMENTAL

Lung ultrasound guided albumin administration group

Drug: Lower albumin dosage

Interventions

Lower albumin dosageDRUG

A fixed dose of 35 grams of albumin on they one and day two.

Also known as: Lung ultrasound guided administration of albumin
Lung ultrasound guided albumin administration group

Eligibility Criteria

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

You may qualify if:

  • Older than 18 years.
  • Decompensated cirrhosis
  • Indication for intravenous albumin use

You may not qualify if:

  • Development of variceal hemorrage before the administration of albumin, respiratory failure previous to albumin use, or the presence of hepatocellular carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Médico ISSEMyM

Metepec, State of Mexico, 52170, Mexico

Location

MeSH Terms

Conditions

FibrosisAcute Kidney InjuryAscites

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 20, 2025

First Posted

July 18, 2025

Study Start

March 1, 2023

Primary Completion

December 14, 2023

Study Completion

November 14, 2024

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations

ME(1)