Novel Prediction Score for Postoperative Acute Renal Failure (ARF) Following Liver Resection (StV 11-2008)

This study has been completed.

Sponsor:

Information provided by:

University of Zurich

ClinicalTrials.gov Identifier:

NCT00743132

First received: August 27, 2008

Last updated: January 22, 2010

Last verified: January 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	August 27, 2008
Last Updated Date	January 22, 2010
Start Date ^ICMJE	April 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 19, 2008)	Predictor score [ Designated as safety issue: Yes ] Incidence of ARF Length of hospital stay [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: August 27, 2008)	Incidence of ARF [ Designated as safety issue: Yes ] Length of hospital stay [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00743132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Novel Prediction Score for Postoperative Acute Renal Failure (ARF) Following Liver Resection
Official Title ^ICMJE	Novel Prediction Score for Postoperative Acute Renal Failure (ARF) Following Liver Resection
Brief Summary	ARF is a frequent event after hepatic resection and therefore clinically highly relevant. There is limited evidence on the incidence of postoperative ARF and its clinical relevance in patients undergoing liver resection. This study will evaluate the incidence of acute renal failure (ARF) after liver resection and its impact on postoperative mortality.
Detailed Description	ARF is a frequent event after hepatic resection and therefore clinically highly relevant. There is limited evidence on the incidence of postoperative ARF and its clinical relevance in patients undergoing liver resection. This study will evaluate the incidence of acute renal failure (ARF) after liver resection and its impact on postoperative mortality.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with benign and malign liver diseases of the Swiss HPB (Hepato-Pancreato-Biliary) Center undergoing liver resection from 2002 - 2007
Condition ^ICMJE	Acute Renal Failure
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 Postoperative no renal dysfunction 2 Postoperative renal dysfunction
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	569
Completion Date	December 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient age >/= 18 years Benign and malign liver diseases Exclusion Criteria: Trauma cases
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT00743132
Other Study ID Numbers ^ICMJE	StV 11-2008, StV 11-2008
Has Data Monitoring Committee	No
Responsible Party	med. pract. Ksenija Slankamenac, Swiss HPB (Hepato-Pancreato-Biliary) Center, Department of Surgery
Study Sponsor ^ICMJE	University of Zurich
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Zurich
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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