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

NCT ID: NCT01318798

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 549 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

Detailed 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.

Conditions

Acute Renal Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with post-operative ARF

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.

No interventions assigned to this group

Patients without post-operative ARF

Patients with normal kidney function (without acute renal failure (ARF)) following liver surgery

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Ksenija Slankamenac

Md PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ksenija Slankamenac, med. pract.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Visceral and Transplantation Surgery

Locations

University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery

Zurich, , Switzerland

Countries

Switzerland

References

Slankamenac K, Breitenstein S, Held U, Beck-Schimmer B, Puhan MA, Clavien PA. Development and validation of a prediction score for postoperative acute renal failure following liver resection. Ann Surg. 2009 Nov;250(5):720-8. doi: 10.1097/SLA.0b013e3181bdd840.

Reference Type: RESULT

PMID: 19809295 (View on PubMed)

Other Identifiers

StV 33-2009

Identifier Type: -

Identifier Source: org_study_id