NCT01243528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 15, 2014

Status Verified

December 1, 2014

Enrollment Period

6 months

First QC Date

November 17, 2010

Last Update Submit

December 12, 2014

Conditions

Malnutrition

Keywords

MalnutritionInfectionNeurological

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Nutritional status is represented by Prognostic Inflammatory and Nutritional Index Score (PINI) and bioimpedanz-anlaysis-measurement (BIA)

    8 weeks

Secondary Outcomes (1)

  • Nosocomial infections

    8 weeks

Study Arms (1)

Patients in neurological rehabilitation

Patients suffering from a neurological disease

Other: Laboratory values

Interventions

Laboratory valuesOTHER

Laboratory values which represent nutritional status

Also known as: Vitamin D, Creatinine, Urea nitrogen, Albumin, Prealbumin, Total protein, C-reactive protein, Triiodothyronine, Thyroxin
Patients in neurological rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in neurological rehabilitation facility

You may qualify if:

  • Patients in early neurological rehabilitation
  • informed consent given

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Clinic Bad Aibling

Bad Aibling, Bavaria, 83043, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

MalnutritionInfectionsNeurologic Manifestations

Interventions

Laboratory Critical ValuesVitamin DCreatinineBlood Urea NitrogenAlbuminsPrealbuminProteinsC-Reactive ProteinTriiodothyronineThyroxine

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBlood Chemical AnalysisClinical Chemistry TestsKidney Function TestsDiagnostic Techniques, UrologicalAmino Acids, Peptides, and ProteinsSerum AlbuminBlood ProteinsAcute-Phase ProteinsImmunoproteinsThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino Acids

Study Officials

  • Marion Mertl-Rötzer, Dr. med.

    Schoen Clinic Bad Aibling

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Physician

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 18, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 15, 2014

Record last verified: 2014-12

Locations

DE(1)