Observational Study at the Influence of Malnutrition on I... | NCT01243528

Studies
Observational Study at the Influence of Malnutrition on Infections

NCT01243528

Sponsor

Marion Mertl-Roetzer

Status

Completed

Last Update Posted

Dec 15, 2014Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Malnutrition

Interventions

Laboratory values

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

Dec 2014

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

Jun 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 17, 2010

First Submission Date that Met QC Criteria

Nov 17, 2010

First Posted Date

Nov 18, 2010Estimated

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

Dec 12, 2014

Last Update Posted Date

Dec 15, 2014Estimated

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 purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. Study population are patients undergoing early neurological rehabilitation.

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

Retention

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients in neurological rehabilitation		Patients suffering from a neurological disease	Other: Laboratory values

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laboratory values	Other	Laboratory values which represent nutritional status	Patients in neurological rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nutritional status	Nutritional status is represented by Prognostic Inflammatory and Nutritional Index Score (PINI) and bioimpedanz-anlaysis-measurement (BIA)	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Nosocomial infections	Survey whether the patient has infections during the observation period	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients in early neurological rehabilitation
informed consent given

Exclusion Criteria:

none

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 in neurological rehabilitation facility

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marion Mertl-Rötzer, Dr. med.	Schoen Clinic Bad Aibling	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schoen Clinic Bad Aibling		Bad Aibling	Bavaria	83043	Germany

Condition Browse Module

MeSH Terms

ID	Term
D044342	Malnutrition
D007239	Infections
D009461	Neurologic Manifestations

Ancestor Terms

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000071117	Laboratory Critical Values
D014807	Vitamin D
D003404	Creatinine
D001806	Blood Urea Nitrogen
D000418	Albumins
D011228	Prealbumin
D011506	Proteins
D002097	C-Reactive Protein
D014284	Triiodothyronine
D013974	Thyroxine

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided