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

Primary Purpose

Oral Cancer, Head and Neck Cancer, Free Flap

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Epinephrine
Norepinephrine
Dobutamine
Dopexamine
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Oral Cancer focused on measuring noradrenaline, norepinephrine, epinephrine, adrenaline, dobutamine, dopexamine, inotrope, pressor, sympathomimetic, free flap, transplantation, free tissue transfer, microsurgery, survival

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pressors

Arm Description

Epinephrine, Norepinephrine, Dobutamine, Dopexamine

Outcomes

Primary Outcome Measures

Absolute change in transfer function (flap vascular resistance) after pressor infusion.

Secondary Outcome Measures

Relative change in transfer function after pressor infusion compared with "normal" tissue.
Change in flap flow after pressor infusion
Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.

Full Information

First Posted
August 15, 2011
Last Updated
August 15, 2011
Sponsor
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01418118
Brief Title
Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery
Acronym
Free4Flow
Official Title
An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oxford University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Head and Neck Cancer, Free Flap, Hypotension
Keywords
noradrenaline, norepinephrine, epinephrine, adrenaline, dobutamine, dopexamine, inotrope, pressor, sympathomimetic, free flap, transplantation, free tissue transfer, microsurgery, survival

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressors
Arm Type
Experimental
Arm Description
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Intervention Description
0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
Intervention Type
Drug
Intervention Name(s)
Dopexamine
Intervention Description
Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg
Primary Outcome Measure Information:
Title
Absolute change in transfer function (flap vascular resistance) after pressor infusion.
Time Frame
Post infusion (at 4 hours)
Secondary Outcome Measure Information:
Title
Relative change in transfer function after pressor infusion compared with "normal" tissue.
Time Frame
Post infusion (at 4 hours)
Title
Change in flap flow after pressor infusion
Time Frame
Post infusion (at 4 hours)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen R Watt-Smith, FDSRCS, MD
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22929242
Citation
Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-570. doi: 10.1097/PRS.0b013e31825dbf73.
Results Reference
derived

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

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