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

Effects of Abdominal Hot Compresses on Indocyanine Green Elimination - a Randomized Cross Over Study in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00484913

Enrollment

Registered

2007-06-12

Start date

2003-09-30

Completion date

2003-12-31

Last updated

2007-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy subjects

Brief 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.

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.

Interventions

PROCEDUREabdominal hot compress

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Indocyanine green half life	40 minutes

Secondary

Measure	Time frame
heart rate, blood pressure	40 minutes

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026