Influence of Perioperative Kidney Function on Postoperati... | NCT01522313

Studies
Influence of Perioperative Kidney Function on Postoperative Outcome

NCT01522313

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Oct 10, 2012Estimated

Enrollment

39,369Actual

Phase

Not provided

Conditions

Renal Insufficiency
Acute Kidney Injury

Interventions

Not provided

Countries

Germany

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

Status Module

Record Verification Date

Oct 2012

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

Jan 2006

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jan 23, 2012

First Submission Date that Met QC Criteria

Jan 27, 2012

First Posted Date

Jan 31, 2012Estimated

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

Oct 8, 2012

Last Update Posted Date

Oct 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, Professor of Anesthesiology, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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

This study investigates the influence of perioperative changes in serum creatinine on hospital length of stay and mortality.

Detailed Description

Not provided

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

39,369Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Data of patients anesthetized in the years 2006 to 2012 (Hospital stay: January 2006 - June 2012) will be analysed in the study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hospital length of stay	once per case	1 year

Secondary Outcomes

Measure	Description	Time Frame
all cause in-hospital mortality	occurrence during hospital stay	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients anesthetized between January 2006 - June 2012

Exclusion Criteria:

end stage renal disease
pre-anesthesiologic need of renal replacement therapy
patients undergoing nephrectomy or kidney transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Retrsospective analysis of electronic charts of all patients that underwent anesthesia between January 2006 - June 2012 in the Department of Anesthesiology at the Charité - University Medicine Berlin, Campus Charité Mitte und Campus Virchow Klinikum.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia D Spies, MD Prof.	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - University Medicine Berlin		Berlin		13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided