Ischemic Preconditioning. Prospective Comparison (IP)
Primary Purpose
Ischemic Lesions
Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
ischemic preconditioning
Sponsored by

About this trial
This is an interventional treatment trial for Ischemic Lesions focused on measuring Ischemic, preconditioning, liver, resection
Eligibility 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
Sites / Locations
- Hospital Dr Cosme ArgerichRecruiting
Outcomes
Primary Outcome Measures
Mortality Complications
Secondary Outcome Measures
Operative variables,markers of liver function and injury, pathological parenchymal characteristics
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
Full Information
NCT ID
NCT01432548
First Posted
August 29, 2011
Last Updated
September 12, 2011
Sponsor
Hospital General de Agudos "Dr. Cosme Argerich"
1. Study Identification
Unique Protocol Identification Number
NCT01432548
Brief Title
Ischemic Preconditioning. Prospective Comparison
Acronym
IP
Official Title
Ischemic Preconditioning Versus Intermittent Portal Triad Clamping in Liver Resection. Prospective Randomized Comparison
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Agudos "Dr. Cosme Argerich"
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Lesions
Keywords
Ischemic, preconditioning, liver, resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ischemic preconditioning
Intervention Description
Surgery with ischemic preconditioning in liver resection
Primary Outcome Measure Information:
Title
Mortality Complications
Time Frame
within 30 days after surgery
Secondary Outcome Measure Information:
Title
Operative variables,markers of liver function and injury, pathological parenchymal characteristics
Description
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
Time Frame
within 30 days after surgey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Lendoire, MD, PhD
Phone
5491160116898
Email
jlendoire@yahoo.com.ar
Facility Information:
Facility Name
Hospital Dr Cosme Argerich
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Lendoire, MD, PhD
Phone
011-4121-0846
Email
• jlendoire@yahoo.com.ar
12. IPD Sharing Statement
Learn more about this trial
Ischemic Preconditioning. Prospective Comparison
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