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Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Acute Renal Failure

Study type

Observational

Funder types

Other

Identifiers

NCT01318798
StV 33-2009

Details and patient eligibility

About

Post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. The enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted ARF following hepatic surgery. This prediction score allows early identification of patients at high risk of ARF and may support decision-making for protective kidney treatment.

Full description

To enhance and validate an already pre-existing score accurately predicting post-operative acute renal failure (ARF) after hepatic surgery

We will enhance a pre-existing score predicting ARF based on pre-operative as well as intra-operative predictors.

Development process: we will identify the strongest predictors of ARF in a multivariable logistic regression model followed by a stepwise backward logistic regression analysis and bootstrapping.

Validation process: we will perform an internal validation by calibrating the prediction model as well as by k-fold cross validation (c statistics) and bootstrapping. Additionally, we will calculate the discrimination by the area under the curve (AUC).

Decision curve analysis: Furthermore we will perform a decision curve analysis to evaluate the clinical consequences of both prediction scores whether a patient with increased ARF risk would post-operative benefit of a treatment on the ICU.

Enrollment

549 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • > 18 years
  • scheduled for liver surgery
  • benign as well as malignant diseases

Exclusion criteria

  • liver trauma
  • incomplete data sets
  • pre-operative chronic renal failure requiring hemodialysis

Trial design

549 participants in 2 patient groups

Patients with post-operative ARF
Description:
Patients developing acute renal failure (ARF) following liver surgery ARF was defined according to the RIFLE criteria as an absolute increase in serum-creatinine of more than 0.3 mg/dl above baseline, or an increase of more than 1.5 times the pre-operative baseline value within 48 hours after surgery, or a reduction of urinary output less than 0.5 ml/kg/h for at least 6 hrs.
Patients without post-operative ARF
Description:
Patients with normal kidney function (without acute renal failure (ARF)) following liver surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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