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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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abdominal hot compress

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Roman Huber, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine II, Freiburg University Hospital, Germany

Locations

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Department of Internal Medicine II, Freiburg University Hospital

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 17623067 (View on PubMed)

Other Identifiers

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LW05

Identifier Type: -

Identifier Source: org_study_id