Acute Kidney Injury, Hepatorenal Syndrome
Conditions
Keywords
NGAL, Acute kidney injury, Cirrhosis, Hepatorenal syndrome
Brief summary
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.
Interventions
None listed
Sponsors
Federal University of Rio Grande do Sul
Federal University of Espirito Santo
Hospital de Base
University of Campinas, Brazil
University of Sao Paulo
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cirrhosis diagnosis by liver biopsy or combination of clinical, laboratorial, endoscopic and imagenological data; * Presence of ascites and/or hepatic hydrothorax; * Age over 18 years old; * Diagnosis of bacterial infection (including spontaneous bacterial peritonitis and others) with or without acute kidney injury (defined as a serum creatinine above 1.5mg/dL at admission) or acute kidney injury without bacterial infection; * Agreement to participate in the study, registered by informed consent;
Exclusion criteria
* Serious comorbidities (functional class IV heart failure, O2 dependent chronic obstructive pulmonary disease, advanced cancer); * Shock, as defined by American College of Chest Physicians; * Chronic kidney disease with serum creatinine persistently above 1.5mg/dL in the previous 6 months and/or with sonographic findings of chronic nephropathy; * Intrinsic nephropathy with hematuria over 50 red cells/high power field and dysmorphic erythrocyte and/or proteinuria over 500mg/24h; * Use of nephrotoxic drugs in the previous 30 days; * Dialysis prior to study inclusion; * Previous solid organ transplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of NGAL to predict no response to albumin expansion | One day after albumin expansion (day 3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment | Treatment period (maximum of 14 days) | 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. |
| Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection | During antibiotic therapy and during hospital stay | 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. |
| Predictors of mortality | In-hospital, 30 days and 90 days | 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. |
| Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis | During treatment period | 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. |
| Accuracy of other biomarkers to predict no response to albumin expansion | One day after albumin expansion (day 3) | 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. |
Countries
Brazil
Contacts
Primary ContactRafael O Ximenes, MD
Outcome results
None listed