CirrhosisPhase 3POCUSNCT07072572
Lung Point of Care Ultrasound to Guide Albumin Administration in Cirrhosis
A Phase 3 study testing Lower albumin dosage in people with Cirrhosis and Cirrhosis Advanced, run by Centro Medico Issemym at 1 site in Mexico.
Trial summary
To guide the administration of intravenous albumin by lung ultrasound in decompensated cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Cirrhosis Advanced, Acute Kidney Injury
- What is being tested?
- Lower albumin dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2023to 14 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Older than 18 years.
- Decompensated cirrhosis
- Indication for intravenous albumin use
Who cannot join
- Development of variceal hemorrage before the administration of albumin, respiratory failure previous to albumin use, or the presence of hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Point Of Care Ultrasond (L-Pocus)-Guided Administration Of Intravenous Albumin In Decompensated Cirrhosis: A Pilot, Open Label, Randomized Controlled Trial
To guide the administration of intravenous albumin by lung ultrasound in decompensated cirrhosis.
- Conditions
- Cirrhosis, Cirrhosis Advanced, Acute Kidney Injury, Ascites
- Being tested
- Lower albumin dosage
- Keywords
- Albumin, Lung ultrasound
- Medical subject headings
- Fibrosis, Acute Kidney Injury, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower albumin dosageDrug
Also called Lung ultrasound guided administration of albumin
A fixed dose of 35 grams of albumin on they one and day two.
| Study group | Role | What they receive |
|---|---|---|
| Conventional albumin group | No intervention | Conventional albumin group |
| Lung ultrasound guided albumin administration group | Experimental | Lung ultrasound guided albumin administration group Receives: Drug: Lower albumin dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality at 30 days
Overall mortality at 30 days
Measured: 30 days
Secondary outcomes (6)
Respiratory failure
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.
Measured: Every 24 hours, during hospitalization, (assesed up to 28 days)
Acute kidney injury
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.
Measured: Every 24 hours, during hospitalization, (assesed up to 28 days)
Resolution of SBP
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.
Measured: Day three of antibiotic treatment initiated for spontaneous bacterial peritonitis.
Development of variceal hemorrhage
Number of Participants with development of variceal hemorrhage: Defined as upper GI bleeding due to gastroesophageal varices confirmed by endoscopy
Measured: During hospitailization, (assesed up to 28 days)
acute-on-chronic liver failure
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.
Measured: During hospitailization, (assesed up to 28 days)
Total hospitalization time
Total hospitalization time
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Mar 2023
- Primary completion14 Dec 2023
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Issemym
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Alejandro Rosales Renteria, Centro Medico Issemym
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072572
- Sponsor's protocol ID
- CMedicoIssemym
- Acronym
- POCUS
- Status last verified
- Jul 2025
- First submitted
- 20 Apr 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Point Of Care Ultrasond (L-Pocus)-Guided Administration Of Intravenous Albumin In Decompensated Cirrhosis: A Pilot, Open Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07072572
- Acronym / sponsor ID
- POCUS / CMedicoIssemym
- Conditions
- Cirrhosis, Cirrhosis Advanced, Acute Kidney Injury, Ascites
- Keywords
- Albumin, Lung ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centro Medico IssemymUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 18 Jul 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.
To guide the administration of intravenous albumin by lung ultrasound in decompensated cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional albumin group | No intervention | –Conventional albumin group |
| Lung ultrasound guided albumin administration group | Experimental | Drug: Lower albumin dosageLung ultrasound guided albumin administration group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years.
- Decompensated cirrhosis
- Indication for intravenous albumin use
Key exclusion criteria (1 listed)
- Development of variceal hemorrage before the administration of albumin, respiratory failure previous to albumin use, or the presence of hepatocellular carcinoma
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 |
|---|---|---|
| Lower albumin dosageAlso: Lung ultrasound guided administration of albuminA fixed dose of 35 grams of albumin on they one and day two. | Drug | Lung ultrasound guided albumin administration group |
Primary outcome
Overall mortality at 30 days
Time frame: 30 days
Overall mortality at 30 days
6 secondary outcomes
Respiratory failure
Time frame: Every 24 hours, during hospitalization, (assesed up to 28 days)
Acute kidney injury
Time frame: Every 24 hours, during hospitalization, (assesed up to 28 days)
Resolution of SBP
Time frame: Day three of antibiotic treatment initiated for spontaneous bacterial peritonitis.
Development of variceal hemorrhage
Time frame: During hospitailization, (assesed up to 28 days)
acute-on-chronic liver failure
Time frame: During hospitailization, (assesed up to 28 days)
Total hospitalization time
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lower albumin dosage in people with Cirrhosis and Cirrhosis Advanced, run by Centro Medico Issemym at 1 site in Mexico.
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 1 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: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall mortality at 30 days (time frame: 30 days). 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 18 Jul 2025.