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OpenTrials
Completed

NCT Number: NCT07072572

Lung Point of Care Ultrasound to Guide Albumin Administration in Cirrhosis

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

Completed

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Key information

Conditions

Cirrhosis Acute Kidney Injury Ascites Cirrhosis Advanced Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro Médico ISSEMyM

Metepec, State of Mexico, 52170, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lower albumin dosage

Drug

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

Other names: Lung ultrasound guided administration of albumin

Primary outcomes

  1. Overall mortality at 30 days

    Time frame: 30 days

    Overall mortality at 30 days

Secondary outcomes

  1. Respiratory failure

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

    Number of Participants with respiratory failure, as defined as a requirement of greater than 10/L min og supplemental oxygen, a SpO2 lower than 92% on room temperature or an arterial blood oxyen concentration (pO2) lower than 60 mmHg.

  2. Acute kidney injury

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

    Number of Participants with acute kidney injury, as defined by the KDIGO criteria, being KDIGO 1 an increment in serum creatinine over baseline values of 0.3 mg/dL, KDIGO 2-2.9 times over baseline, KDIGO 3, 3 times over baseline.

  3. Resolution of SBP

    Time frame: Day three of antibiotic treatment initiated for spontaneous bacterial peritonitis.

    Number of Participants with resolution of SBP: Defined as a reduction of 25% of WBC in ascites performed through check up paracentesis at day three.

  4. Development of variceal hemorrhage

    Time frame: During hospitailization, (assesed up to 28 days)

    Number of Participants with development of variceal hemorrhage: Defined as upper GI bleeding due to gastroesophageal varices confirmed by endoscopy

  5. acute-on-chronic liver failure

    Time frame: During hospitailization, (assesed up to 28 days)

    Number of Participants with development of acute on chronic liver failure, as defined by ther Ec-CLF criteria, which asses biochemical function of six organ systems: liver, kidney, brain, coagulation, circulation, and lungs. Each organ system is graded on a scale of 1 to 3, with higher scores indicating more severe organ dysfunction.

  6. Total hospitalization time

    Time frame: 30 days

    Total hospitalization time

Sponsors and collaborators

Lead sponsor

Centro Medico Issemym

Other

Registry information

Official study title

Lung Point Of Care Ultrasond (L-Pocus)-Guided Administration Of Intravenous Albumin In Decompensated Cirrhosis: A Pilot, Open Label, Randomized Controlled Trial

Acronym: POCUS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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