Trial document





This trial has been registered retrospectively.
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  DRKS00000027

Trial Description

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Title

Effects of abdominal hot compresses on indocyanine green elimination - a randomized cross over study in healthy subjects

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Trial Acronym

LW03

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Abdominal hot compresses are traditionally used by patients with liver diseases as self help. This study investigates the effect of abdominal hot compresses on hepatic blood flow measured by elimination of indocyanin green (ICG), a non-toxic green dye. In healthy volunteers ICG elimination is measured with and without hot compress at two investigations in a weekly interval. At each investigation ICG is injected as bolus after a rest period. After the injection blood is taken in regular intervals for analysis of ICG concentration over a period of 40 minutes and half life is calculated.

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Brief Summary in Scientific Language

Background:
Hot compresses on the right upper abdomen are used as support for patients with liver diseases in Germany. The study was designed to determine, whether they affect hepatic blood flow.
Methods:
Single dose kinetics of indocyanine green (ICG) were studied in 13 healthy subjects with or without hot compresses on the right upper abdomen over 40 minutes. The time interval between the investigations was 8 days, the sequence was randomly assigned.

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Organizational Data

  •   DRKS00000027
  •   2008/09/05
  •   2007/05/22
  •   yes
  •   Approved
  •   154/03, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   NCT00484913  (ClinicalTrials.gov)
  •   UKF001043  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   hepatic blood flow
  •   Hot compresses
  •   K70-K77 -  Diseases of liver
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Placebo
  •   Other
  •   Crossover
  •   I
  •   [---]*
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Primary Outcome

Indocyanine green half life [ Time Frame: 40 minutes ]

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Secondary Outcome

ICG plasma disappearence rate, ICG half life within a two compartment model. heart rate, blood pressure [ Time Frame: 40 minutes ]

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2003/09/01
  •   14
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Healthy volunteers 18-45 years old

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Exclusion Criteria

Iodine allergy, any acute or chronic disease [with exception of pollinosis], elevated levels of alanine amino transferase [ALT], aspartate amino transferase [AST], gamma glutamyltransferase [GGT] or bilirubin, heat urticaria, pregnancy, alcohol intake >30 g/d, any medication except contraceptives and a body mass index (BMI) >30 kg/m2.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg Zentrum für Naturheilkunde
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2003/12/31
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Trial Publications, Results and other Documents

  •   Huber R, Weisser S, Luedtke R. Effects of abdominal hot compresses on indocyanine green elimination--a randomized cross over study in healthy subjects. BMC Gastroenterol. 2007 Jul 10;7:27.
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* This entry means the parameter is not applicable or has not been set.