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

NCT01318798 | Completed

• 1 other identifier: StV 33-2009
• Study Type: observational
• Target: 549
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure

Keywords

Development; Pre- and intra-operative predictors; Acute renal failure; Liver Surgery; Prediction score; Validation; Clinical consequences; Decision curve analysis; predictors of acute renal failure after liver resection

Outcome Measures

Primary Outcomes (1)

• Development of an enhanced prediction score for ARF

  Development of an enhanced but still simple and easy applicable score based on pre- and extended by intra-operative risk factors to predict postoperative ARF in patients scheduled for liver resection

  within 48 hours post-operative

Secondary Outcomes (2)

• Decision curve analysis

  within 48 hours post-operative

• internal validation of the enhanced prediction score

  within 48 hours post-operative

Study Arms (2)

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.

Patients without post-operative ARF

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

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We included consecutively patients undergoing any type of hepatic surgery for benign as well as malignant diseases between July first, 2002 and October 31, 2007 in a single tertiary care center (Swiss Hepato-Pancreato-Biliary (HPB) Centre, University Hospital of Zurich, Switzerland.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 19809295 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ksenija Slankamenac, med. pract.

  University Hospital Zurich, Visceral and Transplantation Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md PhD

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 18, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

CH (1)