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

Head and Neck Cancer Clinical Trial

— Free4Flow  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418118
• Other study ID #: 2008-000073-37 5579
• Secondary ID: 2008 000073 3708
• Status: Completed
• Phase: Phase 4
• First received: August 15, 2011
• Last updated: August 15, 2011
• Start date: October 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2011
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Free Flap
• Head and Neck Cancer
• Head and Neck Neoplasms
• Hypotension
• Oral Cancer

Intervention

Drug:
• Epinephrine
0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg
• Norepinephrine
Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
• Dobutamine
Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
• Dopexamine
Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in transfer function (flap vascular resistance) after pressor infusion.		Post infusion (at 4 hours)	No
Secondary	Relative change in transfer function after pressor infusion compared with "normal" tissue.		Post infusion (at 4 hours)	No
Secondary	Change in flap flow after pressor infusion		Post infusion (at 4 hours)	No
Secondary	Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.		Post infusion (at 4 hours)	No