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

June 8, 2007
June 8, 2007
September 2003
Not Provided
Indocyanine green half life [ Time Frame: 40 minutes ]
Same as current
No Changes Posted
heart rate, blood pressure [ Time Frame: 40 minutes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Healthy
Procedure: abdominal hot compress
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2003
Not Provided

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00484913
LW05
No
Not Provided
University Hospital Freiburg
Not Provided
Principal Investigator: Roman Huber, Dr. Department of Internal Medicine II, Freiburg University Hospital, Germany
University Hospital Freiburg
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP