Prediction of AKI with the need for RRT by the use of cell cycle arrest biomarkers in patients with sepsis or septic shock.

• Conditions: N17.9; A41.9; Acute renal failure, unspecified; Sepsis, unspecified

• Registration Number: DRKS00012446
• Lead Sponsor: niversitätsklinikum Heidelberg Klinik für Anästhesiologie, Nierenzentrum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-16
• Study Completion: 2021-08-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

* Written consent form of study participant or his appointed representative
Sepsis criteria have to be fulfilled (sepsis-3 definition, Singer et al.):
* Suspected infection
* SOFA-Score = 2
and further for septic shock:
* need for vasopressors to maintain a sufficient hemodynamic state (MAP=65mmHg) despite adequate volume replacement
* serum lactate > 2mmol/l

Exclusion Criteria

* non-fulfillment of inclusion criteria
* no urinary catheter
* refusal of participation in the study
* pre-existing RRT dependency or immediate need for RRT on admission

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
* Establishment of a IGFBP-7xTIMP-2 cut-off value for the prediction of AKI stage III with need for RRT in patients with sepsis or septic shock on ICU with high sensitivity and specificity.<br><br>* Evaluation of IGFBP-7xTIMP-2 (cut-off) levels in relation to disease severity (SOFA-Score, APACHE-II-Score, SAPS-Score), survival after 7d, 30d, 60d and 365d, RRT-dependency after 7, 30, 60, 90 and 365d and length of hospital stay.

Secondary Outcome Measures

Name	Time	Method
* Evaluation of other soluble and cell-bound biomarkers of sepsis and AKI concerning disease course, mortality, RRT-dependency as well as renal and general long-term prognosis and AKI pathogenesis<br><br>* Ability of IGFBP-7xTIMP-2 concentrations to distinguish between moderate, severe AKI and AKI with need for RRT (KDIGO 2012).<br><br>* Evaluation of changes in IGFBP-7xTIMP-2 levels over the disease course and the correlation with AKI with need for RRT and RRT-dependency and mortality after 7,30,60,90 and 365d.<br><br>* Correlation of IGFBP-7xTIMP-2 concentrations and established markers of renal function (SCr, Cystatin C).<br><br>* Correlation of IGFBP-7xTIMP-2 concentrations and composite endpoint MAKE („major adverse kidney events): combination of death, RRT-dependency and persistent renal dysfunction on day 7, 30, 60, , 90, 365 after admission.<br><br>* Time correlation of IGFBP-7xTIMP-2 levels, application of nephrotoxic drugs and potential renal dysfunction.<br>