- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01243528
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
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
-
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Bavaria
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Bad Aibling, Bavaria, Germany, 83043
- Schoen Clinic Bad Aibling
-
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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
|
Laboratory values which represent nutritional status
Other Names:
|
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
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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