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CompletedNCT00484913Updated Jun 12, 2007

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

A Phase 1 interventional study of abdominal hot compress in Healthy, sponsored by University Hospital Freiburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-06-12.

Sponsored by University Hospital Freiburg · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Healthy

Keywords

  • healthy subjects
03

In context

Lead sponsor

University Hospital Freiburg is the lead sponsor of 91 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy volunteers

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Interventions

  • Procedureabdominal hot compress
06

What researchers measure

Primary outcomes

  1. Indocyanine green half life

    Time frame: 40 minutes

Secondary outcomes

  1. heart rate, blood pressure

    Time frame: 40 minutes

07

Study locations

1 site
  • Department of Internal Medicine II, Freiburg University Hospital
    Freiburg, Baden Württemberg 79106, Germany
08

References and documents

Publications

  • 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. doi: 10.1186/1471-230X-7-27. PubMed 17623067 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00484913
Lead sponsor
University Hospital Freiburg
First posted
Jun 12, 2007
Start date
Sep 2003
Completion
Dec 2003
Last update
Jun 12, 2007

Study contacts

Roman Huber, Dr.
principal investigator · Department of Internal Medicine II, Freiburg University Hospital, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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