NCT05049278

Brief Summary

The purpose of this pilot study is to investigate whether two major vasopressors (norepinephrine vs. phenylephrine) used for treatment of hypotension during breast reconstruction with free flap transfer surgery have different effects on blood flow of the flap vessel measured by transit time flowmetry. Since there are few prior studies that compared the effects of these two vasopressors on the blood flow of the flap, this study will be conducted in the form of a pilot study in order to establish the evidence for the future randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

September 24, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

September 4, 2021

Last Update Submit

April 30, 2023

Conditions

Blood FlowAnastomotic Failure of FlapFlap NecrosisFlap Ischemia

Keywords

Blood flowFailure of FlapVasopressorPhenylephrineNorepinephrine

Outcome Measures

Primary Outcomes (3)

  • Graft mean blood flow measured using transit time flowmetry

    Mean blood flow (in mL/min) of the graft vessel that was measured using transit time flowmetry

    Intraoperative period

  • Pulsatility of graft vessel measured using transit time flowmetry

    Pulsatility of graft vessel, which is presented as pulsatility index in unitless, that was measured using transit time flowmetry

    Intraoperative period

  • Diastolic filling of the graft vessel measured using transit time flowmetry

    Diastolic filling (in percentage) of the graft vessel that was measured using transit time flowmetry

    Intraoperative period

Secondary Outcomes (14)

  • Graft failure rate in patients received each vasopressor during surgery

    Within seven days after surgery

  • Capillary filling time in patients received each vasopressor during surgery

    Within seven days after surgery

  • Skin necrosis rate in patients received each vasopressor during surgery

    Within seven days after surgery

  • Rate of vascular thrombosis in patients received each vasopressor during surgery

    Within seven days after surgery

  • Rate of wound infection or any wound problem in patients received each vasopressor during surgery

    Within seven days after surgery

  • +9 more secondary outcomes

Study Arms (2)

Norepinephrine

ACTIVE COMPARATOR

Norepinephrine Bitartrate Hydrate : 4 mg/4 mL

Drug: Norepinephrine

Phenylephrine

ACTIVE COMPARATOR

Phenylephrine hydrochloride : 10 mg/1 mL

Drug: Phenylephrine

Interventions

NorepinephrineDRUG

* Continuous drug: norepinephrine 4mg \* 1@ + D5W 200 mL (20 μg/mL) * Range: 0.03 \~ 0.09 μg/kg/min (= 0.1 \~ 0.3 mL/kg/h)

Norepinephrine
PhenylephrineDRUG

* Continuous drug: phenylephrine 10mg \* 5@ + D5W 200 mL (250 μg/mL) * Range: 0.42 \~ 1.26 μg/kg/min (= 0.1 \~ 0.3 mL/kg/h)

Phenylephrine

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Physical Status Classification Grade 1-3
  • Patients with an ECOG score of 0 or 1 when selecting a subject for the study
  • Patients who can provide written consent to participate in clinical trials
  • Patients requiring the use of vasopressor because the mean arterial pressure is not maintained more than 65 mmHg during surgery

You may not qualify if:

  • Patients with peripheral arterial diseases
  • Patients with allergic history to study drugs
  • If surgery on other areas is scheduled at the same time or is an emergency operation
  • Patients with history of previous abdominal surgery involving the flap donor site
  • Pregnant
  • If there are other major medical or psychiatric disorders that may affect treatment response
  • Left ventricular ejection fraction \< 30% or with a history of arrhythmia that is not controlled by medication
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

NorepinephrinePhenylephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seoul National University Hospital

Study Record Dates

First Submitted

September 4, 2021

First Posted

September 20, 2021

Study Start

September 24, 2021

Primary Completion

February 23, 2022

Study Completion

February 23, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

KR(1)