Acute Kidney Injury, Ascites, Cirrhosis, Cirrhosis Advanced
Conditions
Keywords
Albumin, Lung ultrasound
Brief summary
To guide the administration of intravenous albumin by lung ultrasound in decompensated cirrhosis.
Interventions
DRUGLower albumin dosage
A fixed dose of 35 grams of albumin on they one and day two.
Sponsors
Centro Medico Issemym
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality at 30 days | 30 days | Overall mortality at 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | 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. |
| Resolution of SBP | 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. |
| Respiratory failure | 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. |
| acute-on-chronic liver failure | 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. |
| Total hospitalization time | 30 days | Total hospitalization time |
| Development of variceal hemorrhage | 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 |
Countries
Mexico
Outcome results
None listed