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

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ClinicalTrials.gov Identifier: NCT01243528
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Marion Mertl-Roetzer, Schoen Clinic Bad Aibling

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
Malnutrition Other: Laboratory values

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 : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort 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



Primary Outcome Measures :
  1. 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 :
  1. Nosocomial infections [ Time Frame: 8 weeks ]
    Survey whether the patient has infections during the observation period


Biospecimen Retention:   Samples Without DNA
Serum


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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:


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

Responsible Party: Marion Mertl-Roetzer, Head Physician, Schoen Clinic Bad Aibling
ClinicalTrials.gov Identifier: NCT01243528     History of Changes
Other Study ID Numbers: PINI01
First Posted: November 18, 2010    Key Record Dates
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