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Observational Study at the Influence of Malnutrition on Infections

Sponsor
Marion Mertl-Roetzer (Other)
Overall Status
Completed
CT.gov ID
NCT01243528
Collaborator
(none)
100
Enrollment
1
Location
6
Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Laboratory values

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective, Non-interventional Observational Study at the Influence of Malnutrition on Nosocomial Infections in Patients During Early Neurological Rehabilitation
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Patients in neurological rehabilitation

Patients suffering from a neurological disease

Other: Laboratory values
Laboratory values which represent nutritional status
Other Names:
  • Vitamin D
  • Creatinine
  • Urea nitrogen
  • Albumin
  • Prealbumin
  • Total protein
  • C-reactive protein
  • Triiodothyronine
  • Thyroxin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nutritional status [8 weeks]

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

    Secondary Outcome Measures

    1. Nosocomial infections [8 weeks]

      Survey whether the patient has infections during the observation period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients in early neurological rehabilitation

    • informed consent given

    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schoen Clinic Bad Aibling Bad Aibling Bavaria Germany 83043

    Sponsors and Collaborators

    • Marion Mertl-Roetzer

    Investigators

    • Principal Investigator: Marion Mertl-Rötzer, Dr. med., Schoen Clinic Bad Aibling

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marion Mertl-Roetzer, Head Physician, Schoen Clinic Bad Aibling
    ClinicalTrials.gov Identifier:
    NCT01243528
    Other Study ID Numbers:
    • PINI01
    First Posted:
    Nov 18, 2010
    Last Update Posted:
    Dec 15, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Marion Mertl-Roetzer, Head Physician, Schoen Clinic Bad Aibling
    Malnutrition
    Infection
    Neurological
    Additional relevant MeSH terms:
    Infections
    Malnutrition
    Vitamin D

    Study Results

    No Results Posted as of Dec 15, 2014