Trial document





This trial has been registered retrospectively.
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  DRKS00007441

Trial Description

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Title

Nutritional Condition, Activity And Muscle Strength under Home Parenteral Nutrition

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Insufficient oral nutrition due to illness leads to malnutrition which can be compensated by home parenteral nutrition (HPN). To investigate the efficacy of HPN patients' activity, muscle strength, nutritional state, and quality of life will be studied over a course of at least 2 months.

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Brief Summary in Scientific Language

This prospective study "Nutrition status, activity, and muscle strength under home parenteral nutrition" will investigate the course of the nutritional status of 40 patients receiving HPN to evaluate its use and the prognosis under this nutritional therapy. Therefore, muscle strength and activity as well as quality of life and nutritional parameters will be assessed. The anthropometric nutritional medical parameters include the determination of BMI, triceps and biceps skin fold measurements, upper arm circumference, bioimpedance measurement, as well as laboratory parameters (hemoglobin, leukocytes, albumin, CRP). The study will evaluate the value of muscle strength assessments as an easy to determine parameter for the protein nutrition status and to analyze the course under HPN. The other scores and measurements serve as correlation parameters.
The collective is made up of tumor patients and patients with chronic inflammatory bowel diseases.

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Organizational Data

  •   DRKS00007441
  •   2014/11/20
  •   [---]*
  •   yes
  •   Approved
  •   5138, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E43 -  Unspecified severe protein-energy malnutrition
  •   Home Parenteral Nutrition
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Interventions/Observational Groups

  •   Home parenteral nutrition for a least 2 months, activity, BIA, EADL, EORTC-QoL-30CA, muscle strenght
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Measurement of muscle strength (hand dynamometer) and activity (aipermotion), EADL (questionnaire for physical abilities), EORTC-QOL-C30 (questionnaire quality of life).
Documentation before the home parenteral nutrition, then every 4 weeks.

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Secondary Outcome

weight, BMI, BIA, upper arm circumference, blood results ( albumin, hemoglobin, erythrocytes, leucocytes), time of survival.
Documentation before the home parenteral nutrition, then every 4 weeks.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/12/11
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Indication for home parenteral nutrition after the guidelines of the DGEM, written informed consent

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Exclusion Criteria

Expected time of home parenteral nutrition <2 months, expected survival <4 weeks, no written informed consent

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr. med.  Andrea S.  Schneider 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr. med.  Andrea S.  Schneider 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • B.Braun TravaCare GmbH
    • Lilienthalstr. 17
    • 85399  Hallbergmoos
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/08/14
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Trial Publications, Results and other Documents

  •   Jutta Girke, Claudia Seipt, Andrea Markowski, Birgit Luettig, Anika Schettler, Michael Momma, Andrea S. Schneider; Quality of Life and Nutrition Condition of Patients Improve Under Home Parenteral Nutrition: An Exploratory Study Nutr Clin Pract 0884533616637949, first published on May 10, 2016 as doi:10.1177/0884533616637949
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* This entry means the parameter is not applicable or has not been set.