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Observational Study at the Influence of Malnutrition on Infections (Malnutrition)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01243528
First Posted: November 18, 2010
Last Update Posted: December 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marion Mertl-Roetzer, Schoen Clinic Bad Aibling
  Purpose
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 Intervention
Malnutrition Other: Laboratory values

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Marion Mertl-Roetzer, Schoen Clinic Bad Aibling:

Primary Outcome Measures:
  • Nutritional status [ Time Frame: 8 weeks ]
    Nutritional status is represented by Prognostic Inflammatory and Nutritional Index Score (PINI) and bioimpedanz-anlaysis-measurement (BIA)


Secondary Outcome Measures:
  • Nosocomial infections [ Time Frame: 8 weeks ]
    Survey whether the patient has infections during the observation period


Biospecimen Retention:   Samples Without DNA
Serum

Enrollment: 100
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in neurological rehabilitation facility
Criteria

Inclusion Criteria:

  • Patients in early neurological rehabilitation
  • informed consent given

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243528


Locations
Germany
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
  More Information

Responsible Party: Marion Mertl-Roetzer, Head Physician, Schoen Clinic Bad Aibling
ClinicalTrials.gov Identifier: NCT01243528     History of Changes
Other Study ID Numbers: PINI01
First Submitted: November 17, 2010
First Posted: November 18, 2010
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by Marion Mertl-Roetzer, Schoen Clinic Bad Aibling:
Malnutrition
Infection
Neurological

Additional relevant MeSH terms:
Infection
Malnutrition
Nutrition Disorders