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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00484913
First received: June 8, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Procedure: abdominal hot compress
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Abdominal Hot Compresses on Indocyanine Green Elimination – a Randomized Cross Over Study in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Indocyanine green half life [ Time Frame: 40 minutes ]

Secondary Outcome Measures:
  • heart rate, blood pressure [ Time Frame: 40 minutes ]

Enrollment: 14
Study Start Date: September 2003
Study Completion Date: December 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484913

Locations
Germany
Department of Internal Medicine II, Freiburg University Hospital
Freiburg, Baden Württemberg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Roman Huber, Dr. Department of Internal Medicine II, Freiburg University Hospital, Germany
  More Information

Additional Information:
No publications provided by University Hospital Freiburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00484913     History of Changes
Other Study ID Numbers: LW05
Study First Received: June 8, 2007
Last Updated: June 8, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
healthy subjects

ClinicalTrials.gov processed this record on November 20, 2014