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| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
| Federal University of Espirito Santo | OTHER |
| Hospital de Base | OTHER |
| University of Campinas, Brazil |
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The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and to predict response to AKI treatment with albumin and albumin with terlipressin in patients with suspected hepatorenal syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No AKI | Patients with cirrhosis admitted to hospital with bacterial infection with initial serum creatinine below 1.5mg/dL. | ||
| AKI and Infection | Patients with cirrhosis admitted to hospital with bacterial infection and initial serum creatinine above 1.5mg/dL. | ||
| AKI with No Infection | Patients with cirrhosis admitted to hospital with initial serum creatinine above 1.5mg/dL without bacterial infection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of NGAL to predict no response to albumin expansion | We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of NGAL to predict no response to albumin expansion. No response will be defined as an absence of a drop of serum creatinine to a final value below 1.5mg/dL in the day after the end of albumin expansion. Albumin will be administrated as International Ascites Club recommendations, i.e. in the dose of 1g/kg/day for 2 days in patients with suspected hepatorenal syndrome. | One day after albumin expansion (day 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment | We will test the accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment. No response to treatment will be defined as a final value of serum creatinine above 1.5mg/dL after the end of treatment with terlipressin plus albumin. The treatment will be conducted according to International Ascites Club recommendations. |
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Inclusion Criteria:
Exclusion Criteria:
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We will include cirrhotic patients admitted to hospitals participating centers with AKI and/or bacterial infection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rafael O Ximenes, MD | Contact | +55 011 2661-3338 | rximenes@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alberto Q Farias, Associate professor | University of Sao Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Espirito Santo | Not yet recruiting | Vitória | Espírito Santo | 29075-910 | Brazil |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D006530 | Hepatorenal Syndrome |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| OTHER |
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We will store samples of urine and serum frozen at -80oC.
| Treatment period (maximum of 14 days) |
| Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection | We will test the accuracy of urinary NGAL and other biomarkers to predict AKI development and progression during antibiotic therapy and during hospital stay in patients with bacterial infection. AKI will be defined by ICA-AKI criteria. | During antibiotic therapy and during hospital stay |
| Predictors of mortality | We will test clinical and laboratorial data relationship with in-hospital, 30 days and 90 days mortality in a univariate analysis. Associated variables will be tested in a multivariate analysis. | In-hospital, 30 days and 90 days |
| Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis | We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of urinary NGAL to predict adverse events during AKI treatment with albumin alone or in combination with terlipressin. We will also calculate the best cut-off value based on the receiver-operating curve. | During treatment period |
| Accuracy of other biomarkers to predict no response to albumin expansion | We will test the accuracy of other biomarkers to predict no response to albumin expansion. No response will be defined as an absence of a drop of serum creatinine to a final value below 1.5mg/dL in the day after the end of albumin expansion. Albumin will be administrated as International Ascites Club recommendations, i.e. in the dose of 1g/kg/day for 2 days in patients with suspected hepatorenal syndrome. | One day after albumin expansion (day 3) |
| Federal University of Rio Grande do Sul | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| University of Campinas | Not yet recruiting | Campinas | São Paulo | 13083-887 | Brazil |
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| University of Sao Paulo | Recruiting | São Paulo | São Paulo | 05403-010 | Brazil |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |