NCT00484913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
Last Updated

June 12, 2007

Status Verified

June 1, 2007

First QC Date

June 8, 2007

Last Update Submit

June 8, 2007

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Indocyanine green half life

    40 minutes

Secondary Outcomes (1)

  • heart rate, blood pressure

    40 minutes

Interventions

abdominal hot compressPROCEDURE

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine II, Freiburg University Hospital

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (1)

  • 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.

    PMID: 17623067DERIVED

Study Officials

  • Roman Huber, Dr.

    Department of Internal Medicine II, Freiburg University Hospital, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 12, 2007

Study Start

September 1, 2003

Study Completion

December 1, 2003

Last Updated

June 12, 2007

Record last verified: 2007-06

Locations

DE(1)