Observational Study at the Influence of Malnutrition on Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marion Mertl-Roetzer, Schoen Clinic Bad Aibling
ClinicalTrials.gov Identifier:
NCT01243528
First received: November 17, 2010
Last updated: December 12, 2014
Last verified: December 2014
  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 Schoen Clinic Bad Aibling:

Primary Outcome Measures:
  • Nutritional status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Marion Mertl-Roetzer, Head Physician, Schoen Clinic Bad Aibling
ClinicalTrials.gov Identifier: NCT01243528     History of Changes
Other Study ID Numbers: PINI01
Study First Received: November 17, 2010
Last Updated: December 12, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Schoen Clinic Bad Aibling:
Malnutrition
Infection
Neurological

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 26, 2015