Application of the urinary biomarkers TIMP2 and IGFBP7 as early predictors regarding procedure selection for negative fluid balance in septic patients

• Conditions: N17; R65.1; Acute renal failure; Systemic Inflammatory Response Syndrome of infectious origin with organ failure

• Registration Number: DRKS00020212
• Lead Sponsor: niversitätsklinikum Knappschaftkrankenhaus BochumKlinik für Anästhesiologie, Intensivmedizin und Schmerztherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-05
• Study Completion: 2023-08-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-hour difference of the urinary biomarkers TIMP2 and IGFBP7 (as NephroCheck® score: [TIMP-2] x [IGFBP7] / 1000) compared to the baseline

Secondary Outcome Measures

Name	Time	Method
- 4h / 6h / 12h Difference in urinary biomarkers TIMP2 and IGFBP7 (as NephroCheck® score: [TIMP-2] x [IGFBP7] / 1000) compared to baseline<br><br>- 30-day mortality<br><br>- 1-year mortality (360 days)<br><br>- ICU length of stay<br><br>- Major Adverse Kidney Events within 30 days (MAKE30)<br><br>- Major Adverse Kidney Events within 360 days (MAKE360)