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Effects of Abdominal Hot Compresses on Indocyanine Green Elimination in Healthy Subjects

U

University Hospital Freiburg

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Procedure: abdominal hot compress

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

We investigated, whether abdominal hot compresses effect hepatic blood flow. Our hypothesis was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system increase hepatic blood flow.

Full description

Abdominal hot compresses are traditionally used by patients with liver diseases as self help. This study investigated the effect of abdominal hot compresses on hepatic blood flow measured by elimination of indocyanine green (ICG), a non-toxic green dye. It was presumed, that abdominal hot compresses increase hepatic blood flow either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system.

In healthy volunteers ICG elimination was measured with and without hot compress at two investigations in a weekly interval. At each investigation ICG was injected as bolus after a rest period of 10 minutes. After the injection blood was taken in regular intervals for analysis of ICG concentration over a period of 40 minutes and half life was calculated.

The time interval between the investigations was 8 days, the sequence was randomly assigned.

Enrollment

14 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy volunteers

Exclusion criteria

  • iodine allergy
  • any acute or chronic disease [with exception of pollinosis because it is common]
  • 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
  • body mass index (BMI) >30 kg/m2

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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