N17 R65.1
Conditions
Interventions
Group 1: In sepsis patients who should be treated with diuretics for negative fluid balance, the urine biomarkers TIMP2 and IGFBP7 are determined immediately before, 30min, 2h, 4h 6h and 12h after a
Sponsors
Universitätsklinikum Knappschaftkrankenhaus BochumKlinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Intensive care patients within 72 hours after diagnosis of sepsis (suspected infection / proof of infection and increase of the SOFA score by at least 2 points) - Acute kidney damage according to KDIGO criteria with stage 2 or higher (increase of the creatinin value to at least 2 times the baseline or urine excretion <0.5 ml / kg / h over at least 12 hours) - Medically indicated decision to perform a furosemide stress test for a negative fluid balance
Exclusion criteria
Exclusion criteria: Age <18 years - Pregnancy (positive test in women of childbearing age) or lactation - Indication or decision for renal replacement therapy at the time of inclusion - Pre-existing, higher grade chronic renal insufficiency (stage 4 or 5, i.e., GFR <30 ml / min) - Performed renal replacement therapy in the last 90 days - Missing urine excretion (anuria) at inclusion time to an extent making sufficient urine sampling impossible - Kidney transplant within the last 12 months - Intolerance or contraindication regarding administration of furosemide - Expected life time <90 days due to medical conditions not related to sepsis or acute kidney injury - Dependency relationship or employment relationship with the sponsor or examiner - Persons acting on a court or administrative order in an institution are housed - Other reasons which, according to the investigator, render the patient unsuitable for study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-hour difference of the urinary biomarkers TIMP2 and IGFBP7 (as NephroCheck® score: [TIMP-2] x [IGFBP7] / 1000) compared to the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| - 4h / 6h / 12h Difference in urinary biomarkers TIMP2 and IGFBP7 (as NephroCheck® score: [TIMP-2] x [IGFBP7] / 1000) compared to baseline - 30-day mortality - 1-year mortality (360 days) - ICU length of stay - Major Adverse Kidney Events within 30 days (MAKE30) - Major Adverse Kidney Events within 360 days (MAKE360) | — |
Countries
Germany
Contacts
Public ContactTim Rahmel
Universitätsklinikum Knappschaftskrankenhaus BochumKlinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Outcome results
None listed