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The Effect of Remote Ischemic Preconditioning in Patients Undergoing Major Liver Surgery

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ClinicalTrials.gov Identifier: NCT00796588
Recruitment Status : Unknown
Verified November 2008 by Royal Free Hampstead NHS Trust.
Recruitment status was:  Enrolling by invitation
First Posted : November 24, 2008
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust

Tracking Information
First Submitted Date  ICMJE November 21, 2008
First Posted Date  ICMJE November 24, 2008
Last Update Posted Date November 24, 2008
Study Start Date  ICMJE April 2005
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
Does RIPC reduce ischemia reperfusion injury in patients undergoing liver surgery [ Time Frame: 8 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
Changes in liver regeneration [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Remote Ischemic Preconditioning in Patients Undergoing Major Liver Surgery
Official Title  ICMJE The Effect of Remote Ischemic Preconditioning in Patients Undergoing Major Liver Surgery
Brief Summary The project has been designed to determine whether a brief period of leg ischemia will reduce the I/R injury sustained by the liver during liver surgery and liver transplantation. Adult patients (aged above 18) for liver resection (LR group) and for orthotopic liver transplantation (OLT group) will be analysed separately. Patients from each category will be randomised to two groups - a control and a Remote IPC group. In the remote IPC group Ischemic preconditioning will be induced during surgery by applying a pneumatic tourniquet to the upper part of the right thigh and then inflating it to twice the measured systolic arterial pressure in order to occlude the blood supply of the leg for 10 minutes. The tourniquet will then be deflated for 10 minutes to reperfuse the leg. This is repeated thrice to precondition the skeletal muscles of the leg.
Detailed Description

Data Collection & Measurements:

Blood Measurements: Blood will be collected at seven different time points, Baseline, Post IPC, 15 and 90 minutes post IRI and then 6,12 and 24 hours post IRI. At each time point approximately 35 ml of blood will be collected. Samples will be collected for the following measurements: Serum LFT and electrolytes, Serum CPK isozymes, Plasma cytokines, coagulation profile, TEG profile, Plasma cytokines, xanthine and XO/XDH activities, Plasma neutrophil activation, Total plasma Nitrate levels, Plasma lactate and ammonia levels and pulmonary artery blood (from indwelling Swan Ganz) for Plasma Myeloperoxidase levels. Some of these are routine measurements done during and after liver surgery.

Biopsies: Two Liver trucut biopsies - one prior to implantation (and in case of liver resection from the normal remnant liver before occlusion) and the other immediately prior to closure of the abdomen - will be taken to study the changes in tissue oxidation, tissue adhesion molecule upregulation and morphology prior to and after preconditioning.

Intra-operative haemodynamcis: Cardio-pulmonary haemodynamics will be monitored using a Swan-Ganz catheter (if it is clinically indicated and already in place) to note the effects of skeletal muscle ischemic preconditioning on the liver, lungs and the heart. In those patients undergoing liver resection invasive heaemodynamic monitoring will not be performed for the purpose of the study, if not required clinically by the anaesthetists and intensive care physicians. Non-invasive measurements will be made of hepatic and cutaneous circulation using surface Laser Doppler flow meter and Ultra sound probes. Cutaneous microvascular responses to iontophoresis (non-invasive) of acetylcholine, an endothelium-independent vasodilator and sodium nitroprusside, and endothelium-independent vasodilator will be measured using the laser Doppler flow meter. NIRS probes (non -invasive) will be used on the surface of the to measure liver tissue oxygenation. All probes will be properly sterilised prior to application.

Post-operative heamodynamics: Cardio-pulmonary haemodynamics will continue to be monitored using a Swan-Ganz catheter (routinely inserted during liver transplantation) in the post-operative period for 24 hours.

ICG measurements: To assess liver function by injecting 0.5 mg/kg of indocyanine green (ICG) pre-operatively, intra-operatively and post operatively. ICG is routinely used in many liver centres for the assessment of liver function in clinical practise. No additional blood samples will be collected since the uptake and excretion of ICG by the liver will be measured by a non invasive digital pulse densitometric device (ICG Pulsion) connected to the patient by a finger sensor.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Ischemia Reperfusion Injury
Intervention  ICMJE Other: remote preconditioning
Three periods of 10 minute occlusion of blood supply to leg using a pneumatic tourniquet
Other Name: RIPC
Study Arms  ICMJE
  • No Intervention: Control group
    Patients undergoing liver surgery without the designated intervention
    Intervention: Other: remote preconditioning
  • RIPC
    application of pneumatic tourniquet in patients undergoing liver surgery
    Intervention: Other: remote preconditioning
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients above the age of 18 undergoing liver surgery

Exclusion Criteria:

  • Absence of written, informed consent.
  • Patients with symptomatic peripheral vascular disease and absent or weak peripheral pulses.
  • Patients with varicose veins and venous ulcers
  • Patients with blood disorders, eg. sickle cell disease
  • Patients with any localised limb infections eg. cellulitis
  • Pregnancy
  • HIV infection
  • Fulminant sepsis
  • Severe comorbid disease
  • Patients below the age of 18
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00796588
Other Study ID Numbers  ICMJE RFH:6100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Brian R. Davidson, Royal Free Hospital and Medical School
Study Sponsor  ICMJE Royal Free Hampstead NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brian R Davidson, FRCS, MD Royal Free Hospital and medical School
PRS Account Royal Free Hampstead NHS Trust
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP