Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery (Free4Flow)

August 15, 2011 updated by: Oxford University Hospitals NHS Trust

An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study

Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The optimal sympathomimetic drug to support blood pressure without adverse vasoconstriction of free flap circulation remains unknown. This study examined the effects of four agents (epinephrine, norepinephrine, dobutamine and dopexamine) on free flaps following resection of head and neck cancer.

Twenty five patients were recruited to the study. Each patient received an infusion of the four drugs in a random order with an intervening washout period between drugs, at four infusion rates. Continuous free flap skin blood flow monitoring was performed using laser Doppler velocimetry, with a second sensor on normal skin acting as a control. Global cardiovascular variables were monitored using the LiDCO Rapid pulse contour analysis system.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.

Exclusion Criteria:

  • Pregnancy
  • Weight >100kg
  • Contraindications to pressor infusions
  • Overnight ventilation not indicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pressors
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
Drug: Epinephrine
0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg
Drug: Norepinephrine
Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
Drug: Dobutamine
Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
Drug: Dopexamine
Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in transfer function (flap vascular resistance) after pressor infusion.
Time Frame: Post infusion (at 4 hours)
Post infusion (at 4 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative change in transfer function after pressor infusion compared with "normal" tissue.
Time Frame: Post infusion (at 4 hours)
Post infusion (at 4 hours)
Change in flap flow after pressor infusion
Time Frame: Post infusion (at 4 hours)
Post infusion (at 4 hours)
Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.
Time Frame: Post infusion (at 4 hours)
Post infusion (at 4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Investigators

  • Principal Investigator: Stephen R Watt-Smith, FDSRCS, MD, Oxford University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-000073-37 5579
  • 2008 000073 37 (EudraCT Number)
  • 08/H0606/31 (Other Identifier: Oxfordshire Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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