Novel Prediction Score for Postoperative Acute Renal Fail... | NCT00743132

Studies
Novel Prediction Score for Postoperative Acute Renal Failure (ARF) Following Liver Resection

NCT00743132

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jan 25, 2010Estimated

Enrollment

569Actual

Phase

Not provided

Conditions

Acute Renal Failure

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
StV 11-2008

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Aug 27, 2008

First Submission Date that Met QC Criteria

Aug 27, 2008

First Posted Date

Aug 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2010

Last Update Posted Date

Jan 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

569Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Postoperative no renal dysfunction
2		Postoperative renal dysfunction

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Predictor score
Incidence of ARF Length of hospital stay

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient age >/= 18 years
Benign and malign liver diseases

Exclusion Criteria:

Trauma cases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with benign and malign liver diseases of the Swiss HPB (Hepato-Pancreato-Biliary) Center undergoing liver resection from 2002 - 2007

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swiss HPB (Hepato-Pancreato-Biliary) Center of the University Hospital Zurich		Zurich	Canton of Zurich	8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19809295	Derived	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.

ID	Term
D058186	Acute Kidney Injury
D014095	Tooth, Impacted

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases