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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012446

Enrollment

200

Registered

2017-05-16

Start date

2017-05-22

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N17.9 A41.9

Interventions

Group 1: AKI with need for RRT (predefined, restrictive criteria) Group 2: No AKI or AKI Stage I (mild AKI), KDIGO AKI-Guidelines 2012. Group 3: AKI stage II or III without need for RRT (moderate or s

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
* 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. * 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.	—

Measure

Time frame

* 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. * 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.

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Secondary

Measure	Time frame
* 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 * Ability of IGFBP-7xTIMP-2 concentrations to distinguish between moderate, severe AKI and AKI with need for RRT (KDIGO 2012). * 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. * Correlation of IGFBP-7xTIMP-2 concentrations and established markers of renal function (SCr, Cystatin C). * 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. * Time correlation of IGFBP-7xTIMP-2 levels, application of nephrotoxic drugs and potential renal dysfunction.	—

Measure

Time frame

* 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 * Ability of IGFBP-7xTIMP-2 concentrations to distinguish between moderate, severe AKI and AKI with need for RRT (KDIGO 2012). * 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. * Correlation of IGFBP-7xTIMP-2 concentrations and established markers of renal function (SCr, Cystatin C). * 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. * Time correlation of IGFBP-7xTIMP-2 levels, application of nephrotoxic drugs and potential renal dysfunction.

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Countries

Germany

Contacts

Public ContactChristian Nusshag

Nierenzentrum Heidelberg

Christian.Nusshag@med.uni-heidelberg.de06221/5634952

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026