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

This study has been completed.
Sponsor:
Information provided by:
Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01418118
First received: August 15, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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 Intervention Phase
Oral Cancer
Head and Neck Cancer
Free Flap
Hypotension
Drug: Epinephrine
Drug: Norepinephrine
Drug: Dobutamine
Drug: Dopexamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • Absolute change in transfer function (flap vascular resistance) after pressor infusion. [ Time Frame: Post infusion (at 4 hours) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative change in transfer function after pressor infusion compared with "normal" tissue. [ Time Frame: Post infusion (at 4 hours) ] [ Designated as safety issue: No ]
  • Change in flap flow after pressor infusion [ Time Frame: Post infusion (at 4 hours) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Oxford University Hospitals NHS Trust

Additional 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, 08/H0606/31
Study First Received: August 15, 2011
Last Updated: August 15, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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
Dobutamine
Dopexamine
Norepinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics

ClinicalTrials.gov processed this record on July 22, 2014