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Prevention of Liver Damage During Liver Surgery (LTR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845689
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ludwig-Maximilians - University of Munich
  Purpose
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.

Condition Intervention Phase
Liver Tumors Drug: placebo Drug: adenosine Procedure: Liver resection Phase 1 Phase 2

Study Type: Interventional
Official Title: Study on the Potential Role of Intraoperative Hepatoprotection During Liver Resections

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Arms Assigned Interventions
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
Drug: adenosine
intravenous infusion of adenosine 0, 2 %
Procedure: Liver resection
Liver resection with Pringle maneuver
Active Comparator: 3
liver resection with Pringle + adenosine pre- and postconditioning
Drug: adenosine
intravenous infusion of adenosine 0,2 %
Procedure: Liver resection
Liver resection with Pringle maneuver

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Prof. Dr. Manfred Thiel, Department of Anaesthesiology of the Ludwig-Maximilians-University
ClinicalTrials.gov Identifier: NCT00845689     History of Changes
Other Study ID Numbers: LMU-202-LTR
First Submitted: February 17, 2009
First Posted: February 18, 2009
Last Update Posted: February 18, 2009
Last Verified: February 2009

Keywords provided by Ludwig-Maximilians - University of Munich:
liver surgery

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Adenosine
Hematinics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action