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

NCT00796588 | Unknown

• 1 other identifier: RFH:6100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia Reperfusion Injury

Keywords

preconditioning; remote

Outcome Measures

Primary Outcomes (1)

• Does RIPC reduce ischemia reperfusion injury in patients undergoing liver surgery

  8 years

Secondary Outcomes (1)

• Changes in liver regeneration

  1 year

Study Arms (2)

Control group

NO INTERVENTION

Patients undergoing liver surgery without the designated intervention

Other: remote preconditioning

RIPC

OTHER

application of pneumatic tourniquet in patients undergoing liver surgery

Other: remote preconditioning

Interventions

remote preconditioning OTHER

Three periods of 10 minute occlusion of blood supply to leg using a pneumatic tourniquet

Also known as: RIPC

Control group; RIPC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above the age of 18 undergoing liver surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Free Hampstead NHS Trust: lead

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (2)

• Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.

  PMID: 18456674 BACKGROUND

• Robertson FP, Goswami R, Wright GP, Fuller B, Davidson BR. Protocol for a prospective randomized controlled trial of recipient remote ischaemic preconditioning in orthotopic liver transplantation (RIPCOLT trial). Transplant Res. 2016 Apr 6;5:4. doi: 10.1186/s13737-016-0033-4. eCollection 2016.

  PMID: 27054029 DERIVED

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian R Davidson, FRCS, MD

  Royal Free Hospital and medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: April 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 24, 2008

Record last verified: 2008-11

Locations

GB (1)