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Prevention of Liver Damage During Liver Surgery (LTR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00845689
First received: February 17, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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:

MedlinePlus related topics: Cancer Liver Cancer
Drug Information available for: Adenosine
U.S. FDA Resources

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

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

No publications provided

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
Study First Received: February 17, 2009
Last Updated: February 17, 2009
Health Authority: Germany: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

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
Adenosine
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013