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

December 12, 2014 updated by: Marion Mertl-Roetzer

Prospective, Non-interventional Observational Study at the Influence of Malnutrition on Nosocomial Infections in Patients During Early Neurological Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Bad Aibling, Bavaria, Germany, 83043
        • Schoen Clinic Bad Aibling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in neurological rehabilitation facility

Description

Inclusion Criteria:

  • Patients in early neurological rehabilitation
  • informed consent given

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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
  • Albumin
  • Creatinine
  • Triiodothyronine
  • C-reactive protein
  • Urea nitrogen
  • Prealbumin
  • Total protein
  • Thyroxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 8 weeks
Nutritional status is represented by Prognostic Inflammatory and Nutritional Index Score (PINI) and bioimpedanz-anlaysis-measurement (BIA)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nosocomial infections
Time Frame: 8 weeks
Survey whether the patient has infections during the observation period
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marion Mertl-Roetzer

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 17, 2010

First Submitted That Met QC Criteria

November 17, 2010

First Posted (Estimate)

November 18, 2010

Study Record Updates

Last Update Posted (Estimate)

December 15, 2014

Last Update Submitted That Met QC Criteria

December 12, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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