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This is a phase IV, unicentric, open-label. Patients eligible for this study will be patients with AKI 1B or greater and decompensated cirrhosis from the hospital participating in the study
This is a phase IV, unicentric, open-label, randomized clinical trial to evaluate the efficacy of intravenous human albumin administration versus saline solution (NaCl 0.9%) in patients with decompensated cirrhosis and AKI 1B or grater.
Patients will be randomized to receive (1:1):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Albumin | No Intervention | Intravenous Human Albumin 20% (20 g/100 ml), at a dose of 1 g per kg body weight with a maximum of 100 g per day, during 48 hours. | |
| Saline solution | Experimental | Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline solution (NaCl 0.9%) | Drug | Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| probability of AKI resolution among patients with decompensated cirrhosis and AKI 1B or greater acute kidney injury (AKI) clinical efficacy of HA versus saline (NaCl 0.9%) administration in patients will be evaluated, | defining AKI resolution as the proportion of patients with a decrease in serum creatinine levels < 0.3 mg/dL with respect to baseline serum creatinine, without the need for TRT. | at any time during the study (all visits: screenning, basal , day 1, day2, day 5, day 7, day 15, and day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate patients | Survival rate patients at 28 days, considering liver transplantation as a competitive risk event. | at 28 days (visit 6) |
| AKI improvement | defined as the proportion of patients who decrease at least 1 grade of AKI classification (from 3 to 2, from 2 to 1B, and from 1B to 1A or recovery), without the need for RRT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana CRUCETA, Md | Contact | +34 932275400 | acruceta@recerca.clinic.cat |
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This is a phase IV, unicentric, open-label, randomized clinical trial, low interventional level
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| basal visit , day 1, day2, day 5, day 7, day 15, and day 28) |
| Proportion of patients requiring RRT In both groups | Proportion of patients requiring RRT In both groups (renal replacemtent theraphy) | basal visit , day 1, day2, day 5, day 7, day 15, and day 28) |
| Changes from baseline in systemic inflammatory response, evaluated by measurement in a large array of plasma cytokine levels (IL-6, IL8, IL-10, IL-1β) | picograms per mililiter (pg/mL) | basal visit , day 1, day2, day 5, day 7, day 15, and day 28) |
| Changes from baseline in systemic inflammatory response, evaluated by measurement in TNFα, | picograms per mililiter (pg/mL) | basal visit , day 1, day2, day 5, day 7, day 15, and day 28) |
| Changes from baseline inG-CSF | micrograms per kilogram of body weight (mcg/kg) | basal visit , day 1, day2, day 5, day 7, day 15, and day 28) |
| Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma copeptin | ypically range from 1 to 13 pmol/L | basal visit , day 1, day2, day 5, day 7, day 15, and day 28), |
| Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration | ng/mL/hr (nanograms per milliliter per hour) | basal visit , day 1, day2, day 5, day 7, day 15, and day 28) |
| Changes in echocardiographic parameters (E/E', ITV, among others) at visit 1, 2, 7 and 28. | (E/E', ITV) | basal visit , day 1, day2, day 7, day, and day 28) |
| Proportion of patients and severity of treatment-related adverse events during the study period | number and description SAEs and SUSARs | screening visit,basal visit , day 1, day2, day 5, day 7, day 15, and day 28) |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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