Trial document





This trial has been registered retrospectively.
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  DRKS00000617

Trial Description

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Title

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

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this trial is to determine whether nutritional status has an impact on the frequenzy of infections. Patients with malnutrition suffer more often from infections, which in turn results in increased mortality.
Study population are 100 patients undergoing early neurological rehabilitation, as these bear an increased risc of malnutrition. For the determination of the nutritional status we once raise laboratory values, measurement of body composition as well as skinfold thickness of triceps and circumference of upper arm. At the begin and the end of an 8week observation period we collect data regarding anamnesis, infections and mortality. From 100 patients we select 15 patients with the worst and 15 patients with the best nutritional status and compare these groups.

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Brief Summary in Scientific Language

In this study we investigate the influence of malnutrition on nosocomial infections. The nutrition status is derived from the following parameter:
Laboratory values: 25-OH-VitaminD3, Creatinine, Urea, Albumine, Prealbumine, Total Protein, CRP, T3, T4, Interleucin-6. Herefrom we calculate the PINI-Score (Prognostic Inflammation and Nutrition Index). Visit 1 will be performed at the beginning of neurological early rehabilitation. Observation period lasts 8 weeks. From 100 patients we select 15 risk-group-patients with the worst and 15 control-group-patients with the best PINI-Score to compare these groups regarding frequenzy of nosocomial infections and mortality.

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Organizational Data

  •   DRKS00000617
  •   2010/11/24
  •   2010/11/18
  •   yes
  •   Approved
  •   10022, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   U1111-1118-2701 
  •   NCT01243528  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   E46 -  Unspecified protein-energy malnutrition
  •   B99 -  Other and unspecified infectious diseases
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Interventions/Observational Groups

  •   Laboratory values to evaluate the nutritional status (blood collection necessary), BIA measurement, measurement of treceps skinfold and circumference of upper arm.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

In week 1 we collect infection status (frequency of nosocomial infections), nutrition status (using bioelectriacal-impedance-analysis, laboratory values, nutritional risc score), mobility (using motor function assessment scale and modified rankin scale). During 8 weeks observation period we note infections and mortality. After 8 weeks we compare 15 patients with the best and 15 patients with the worst PINI-Score regarding infections.

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Secondary Outcome

Mortality is recorded from week 1 to 8. After week 8 we compare the risc group (15 patients with the worst PINI-score) with the controll group (15 patients with the best PINI-score) regarding mortality.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/06/28
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients in early neurological rehabilitation, informed consent

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Exclusion Criteria

Informed consent missing

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Schoen-Klinik Bad Aibling
    • Ms.  Dr.  Marion  Mertl-Roetzer 
    • Kolbermoorer Straße 72
    • 83043  Bad Aibling
    • Germany
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    • Schoen-Klinik Bad Aibling
    • Ms.  Dr.  Marion  Mertl-Roetzer 
    • Kolbermoorer Straße 72
    • 83043  Bad Aibling
    • Germany
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    • Schoen-Klinik Bad Aibling
    • Ms.  Barbara  Schaepers 
    • Kolbermoorer Straße 72
    • 83043  Bad Aibling
    • Germany
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Sources of Monetary or Material Support

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    • Schoen Klinik Bad Ailbing
    • Kolbermoorer Straße 72
    • 83043  Bad Aibling
    • Germany
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    •   08061-903-0
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/10/14
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.