Impaired Preoperative Nutritional Status as a Risk Factor... | NCT01492946

Studies
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome

NCT01492946

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jan 23, 2017Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Nutritional Status

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

Jan 2017

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

May 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Jul 2012Actual

First Submitted Date

Dec 14, 2011

First Submission Date that Met QC Criteria

Dec 14, 2011

First Posted Date

Dec 15, 2011Estimated

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 20, 2017

Last Update Posted Date

Jan 23, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, study director, 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

The aim of this retrospective observational study is to determine the impact of preoperative nutritional status on postoperative outcome. Elective surgical patients were screened with Bio-Impedance-Analysis, Malnutritional Universal Screening Tool, and other variables for body composition. Outcome parameters were collected by patient chart review.

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elective surgical patients		Elective surgical patients in the Charité University Berlin Campus Charité Mitte

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase-angle		preoperative

Secondary Outcomes

Measure	Description	Time Frame
body weight		preoperative
body mass index (BMI)		preoperative
preoperative weight loss

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective surgical intervention
Patients must be 18 years or older
Ambulation
ASA-Score I-IV
bioelectrical impedance analysis to determine the phase angle

Exclusion Criteria:

Emergency surgery
Pregnancy
ASA Score V-VI
Amputated limbs
Pacemaker and defibrillators
Cerebrovascular events
Tattoos on the electrode locations

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

Elective surgical patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia Spies, MD Prof.	Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University, Berlin, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Operative Intensive Care Medicine Campus Charité Mitte, Charite University,		Berlin	State of Berlin	10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided