Prevention of Liver Damage During Liver Surgery (LTR)

February 17, 2009 updated by: Ludwig-Maximilians - University of Munich

Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections

Liver damage as a consequnce of ischemia (I) and reperfusion (R) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. In order to protect the liver from ischemic damage following interventions such as the Pringle Maneuver, preconditioning has been successfully applied in various animal models as well as in humans. Since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. Moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • elective resection of liver tumors
  • age 18 to 80 years
  • informed consent

Exclusion Criteria:

  • chronic obstructive pulmonary disease
  • heart insufficiency NYHA III-IV
  • atrio-ventricular conductance blockage II. (Mobitz) or III. degree
  • atrial fibrillation
  • coronary heart disease (CCS III. or IV. degree)
  • arterial hypertension
  • acute renal failure
  • increased intracranial pressure
  • gout
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
liver resection with Pringle + placebo
Drug: placebo
NaCl 0,9 %
Procedure: Liver resection
Liver resection with Pringle maneuver
Active Comparator: 2
liver resection with Pringle + adenosine preconditiong
Procedure: Liver resection
Liver resection with Pringle maneuver
Drug: adenosine
intravenous infusion of adenosine 0, 2 %
Drug: adenosine
intravenous infusion of adenosine 0,2 %
Active Comparator: 3
liver resection with Pringle + adenosine pre- and postconditioning
Procedure: Liver resection
Liver resection with Pringle maneuver
Drug: adenosine
intravenous infusion of adenosine 0, 2 %
Drug: adenosine
intravenous infusion of adenosine 0,2 %

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMU-202-LTR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Tumors

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe