We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01418118
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : August 16, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Oral Cancer Head and Neck Cancer Free Flap Hypotension Drug: Epinephrine Drug: Norepinephrine Drug: Dobutamine Drug: Dopexamine Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study
Study Start Date : October 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Absolute change in transfer function (flap vascular resistance) after pressor infusion. [ Time Frame: Post infusion (at 4 hours) ]

Secondary Outcome Measures :
  1. Relative change in transfer function after pressor infusion compared with "normal" tissue. [ Time Frame: Post infusion (at 4 hours) ]
  2. Change in flap flow after pressor infusion [ Time Frame: Post infusion (at 4 hours) ]
  3. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418118


Locations
United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Stephen R Watt-Smith, FDSRCS, MD Oxford University Hospitals NHS Trust
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr SR Watt-Smith, Oxford Radcliffe Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01418118     History of Changes
Other Study ID Numbers: 2008-000073-37 5579
2008 000073 37 ( EudraCT Number )
08/H0606/31 ( Other Identifier: Oxfordshire Research Ethics Committee )
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011

Keywords provided by Oxford University Hospitals NHS Trust:
noradrenaline
norepinephrine
epinephrine
adrenaline
dobutamine
dopexamine
inotrope
pressor
sympathomimetic
free flap
transplantation
free tissue transfer
microsurgery
survival

Additional relevant MeSH terms:
Head and Neck Neoplasms
Hypotension
Mouth Neoplasms
Neoplasms by Site
Neoplasms
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Epinephrine
Racepinephrine
Norepinephrine
Dobutamine
Dopexamine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents