Observational Study at the Influence of Malnutrition on Infections
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Schoen Clinic Bad Aibling.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Schoen Clinic Bad Aibling
Information provided by:
Schoen Clinic Bad Aibling
ClinicalTrials.gov Identifier:
NCT01243528
First received: November 17, 2010
Last updated: November 18, 2010
Last verified: November 2010
| Tracking Information | |||||
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| First Received Date ICMJE | November 17, 2010 | ||||
| Last Updated Date | November 18, 2010 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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) |
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| Original Primary Outcome Measures ICMJE |
Nutritional status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] Nutritional status is represented by PINI-Score and BIA-Measurement |
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| Change History | Complete list of historical versions of study NCT01243528 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Nosocomial infections [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] Survey whether the patient has infections during the observation period |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observational Study at the Influence of Malnutrition on Infections | ||||
| Official Title ICMJE | Prospective, Non-interventional Observational Study at the Influence of Malnutrition on Nosocomial Infections in Patients During Early Neurological Rehabilitation | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum |
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| Sampling Method | Probability Sample | ||||
| Study Population | Patients in neurological rehabilitation facility |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Laboratory values
Laboratory values which represent nutritional status
Other Names:
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| Study Group/Cohort (s) | Patients in neurological rehabilitation
Patients suffering from a neurological disease
Intervention: Other: Laboratory values |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01243528 | ||||
| Other Study ID Numbers ICMJE | PINI01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Marion Mertl-Rötzer, Dr. med., Neurological Clinic Bad Aibling | ||||
| Study Sponsor ICMJE | Schoen Clinic Bad Aibling | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Schoen Clinic Bad Aibling | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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