NCT02241083

Brief Summary

Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

7.9 years

First QC Date

September 12, 2014

Last Update Submit

September 15, 2014

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites

    72 hours

Study Arms (3)

dopamine group

ACTIVE COMPARATOR

vasopressor dosage individually titred according to the mean arterial pressure

Drug: Dopamine

norepinephrine group

ACTIVE COMPARATOR

vasopressor dosage individually titred according to the mean arterial pressure

Drug: Norepinephrine

control group

ACTIVE COMPARATOR

no medication

Other: no medication

Interventions

DopamineDRUG
dopamine group
NorepinephrineDRUG
norepinephrine group
no medicationOTHER
control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • head and neck cancer patients having tumor ablation surgery and reconstruction with microvascular radial forearm flap

You may not qualify if:

  • Patients having contraindications for the operation.
  • Patient refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, P.O. Box 2000, 33521, Finland

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

DopamineNorepinephrine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsEthanolaminesAmino AlcoholsAlcohols

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Senior Consultant, Associate Chief

Study Record Dates

First Submitted

September 12, 2014

First Posted

September 16, 2014

Study Start

June 1, 2006

Primary Completion

May 1, 2014

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

FI(1)