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Ischemic Preconditioning. Prospective Comparison (IP)

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 September 2011 by Juan Marcelo Rivaldi, Hospital General de Agudos "Dr. Cosme Argerich".
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432548
First Posted: September 13, 2011
Last Update Posted: September 13, 2011
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 (Responsible Party):
Juan Marcelo Rivaldi, Hospital General de Agudos "Dr. Cosme Argerich"
  Purpose
Vascular occlusion is used to reduce blood loss during liver resection (LR), but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. This restriction of blood flow (ischemia) and subsequent restoration (reperfusion) causes a harm that is called ischemia- reperfusion injury. Injuries sustained during the ischemic phase are related to a lack of oxygen to reduce cellular respiratory events can lead to, in a few minutes, irreversible damage. Ischemic preconditioning as a technique to protect the liver parenchyma during liver resection consists of an initial flow clamping for 10 minutes, with subsequent reperfusion for 10-15min, followed by a complete portal triad clamping during transection.

Condition Intervention
Ischemic Lesions Procedure: ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ischemic Preconditioning Versus Intermittent Portal Triad Clamping in Liver Resection. Prospective Randomized Comparison

Further study details as provided by Juan Marcelo Rivaldi, Hospital General de Agudos "Dr. Cosme Argerich":

Primary Outcome Measures:
  • Mortality Complications [ Time Frame: within 30 days after surgery ]

Secondary Outcome Measures:
  • Operative variables,markers of liver function and injury, pathological parenchymal characteristics [ Time Frame: within 30 days after surgey ]
    Operative time Transection time Operative blood loss Transection area Intraoperative haemodynamic and gases parameters (CVP, MAP) Requirement of blood products. ICU and total length of hospital stay Markers of liver function (Bilirrubin, prothtrombin time) Markers of liver injury (aspartate aminotransferase (AST), alanine aminotransferase (ALT) Pathological parenchymal characteristics


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: ischemic preconditioning
    Surgery with ischemic preconditioning in liver resection
Detailed Description:

Detailed Description:

This is a prospective controlled trial, conducted between July 2011 and July 2012. This study has been initiated by Liver & Transplant Division, Hospital Dr Cosme Argerich, Buenos Aires Argentina. The protocol was approved by ethics committees and an informed consent was obtained from each patient before they were enrolled. Sixty patients were randomized to either receive ischemic preconditioning prior to liver resection under intermittent pedicle clamping or Intermittent Pringle ischemia. Ischemic preconditioning was performed through a sequence of 10 minutes vascular inflow occlusion and 10 minutes of reperfusion prior to continuous pedicle clamping during resection. Intermittent pedicle clamping was conducted through a sequence of 15 minutes of vascular inflow occlusion and 5 minutes of reperfusion. The randomization process which was centralized was held in the operating room after inclusion criteria had been check and exclusion criteria ruled out.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients' age ≥ 18 years old
  • Portal vein embolization allowed

Exclusion Criteria:

  • laparoscopic liver resection
  • pregnant women
  • lack of patient consent
  • lack of acceptance of the operating surgeon
  • Hilar cholangiocarcinoma
  • Simultaneous hepaticojejunostomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432548


Contacts
Contact: Javier Lendoire, MD, PhD 5491160116898 jlendoire@yahoo.com.ar

Locations
Argentina
Hospital Dr Cosme Argerich Recruiting
Buenos Aires, Argentina
Contact: Javier Lendoire, MD, PhD    011-4121-0846    • jlendoire@yahoo.com.ar   
Sponsors and Collaborators
Hospital General de Agudos “Dr. Cosme Argerich”
  More Information

Responsible Party: Juan Marcelo Rivaldi, Ischemic preconditioning vs intermittent portal triad clamping in liver resection. Prospective Randomized Comparison, Hospital General de Agudos "Dr. Cosme Argerich"
ClinicalTrials.gov Identifier: NCT01432548     History of Changes
Other Study ID Numbers: JLendoire2
First Submitted: August 29, 2011
First Posted: September 13, 2011
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Juan Marcelo Rivaldi, Hospital General de Agudos "Dr. Cosme Argerich":
Ischemic
preconditioning
liver
resection

Additional relevant MeSH terms:
Ischemia
Pathologic Processes