search
Back to results

Effects of Vasopressor on the Graft Blood Flow in TRAM

Primary Purpose

Blood Flow, Anastomotic Failure of Flap, Flap Necrosis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Norepinephrine
Phenylephrine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Flow focused on measuring Blood flow, Failure of Flap, Vasopressor, Phenylephrine, Norepinephrine

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Norepinephrine

Phenylephrine

Arm Description

Norepinephrine Bitartrate Hydrate : 4 mg/4 mL

Phenylephrine hydrochloride : 10 mg/1 mL

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Graft failure rate in patients received each vasopressor during surgery
The rate of graft failure in patients received each vasopressor during surgery
Capillary filling time in patients received each vasopressor during surgery
Capillary filling time, which was measured by time to refill the capillary after compression, to evaluate the viability of the flap in patients received each vasopressor during surgery
Skin necrosis rate in patients received each vasopressor during surgery
The rate of skin necrosis, which is evaluated by any changes in skin color by description of the color of the skin by clinicians, to evaluate the viability of the graft in patients received each vasopressor during surgery
Rate of vascular thrombosis in patients received each vasopressor during surgery
The rate of arterial or venous complication by measure of skin color change or decrease in doppler flow or capillary refill to evaluate the viability of the graft in patients received each vasopressor during surgery
Rate of wound infection or any wound problem in patients received each vasopressor during surgery
The rate of any wound complication including infection to evaluate wound complication after surgery in patients each vasopressor during surgery
Amount of transfusion in patients received each vasopressor during surgery
Amount of transfusion to evaluate clinical outcomes in patients received each vasopressor during surgery
Total amount of remifentanil infused during surgery in patients received each vasopressor
The total amount of remifentanil infused during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor
The total amount of inotropic agents or vasopressor during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
Stroke volume during surgery in patients received each vasopressor
Stroke volume (in mL) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Cardiac index during surgery in patients received each vasopressor
Cardiac index (in L/min/m^2) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Stroke volume variation during surgery in patients received each vasopressor
Stroke volume variation (in percentage) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Serum lactate levels in patients received each vasopressor
Serum lactate levels (in mmol/L) to evaluate the postoperative variables and clinical outcomes in patients received each vasopressor during surgery
Wound exploration rate in patients received each vasopressor during surgery
The rate of wound exploration as a measure of postoperative complication and graft failure to evaluate the flap outcome in patients received each vasopressor during surgery
Reoperation rate in patients received each vasopressor during surgery
The rate of reoperation as a measure of postoperative complication and graft failure to evaluate the flap outcome in patients received each vasopressor during surgery

Full Information

First Posted
September 4, 2021
Last Updated
April 30, 2023
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05049278
Brief Title
Effects of Vasopressor on the Graft Blood Flow in TRAM
Official Title
Effects of Norepinephrine vs. Phenylephrine on the Graft Blood Flow Measured by Transit Time Flowmetry in Breast Reconstruction With Free Flap Transfer Surgery: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Flow, Anastomotic Failure of Flap, Flap Necrosis, Flap Ischemia
Keywords
Blood flow, Failure of Flap, Vasopressor, Phenylephrine, Norepinephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norepinephrine
Arm Type
Active Comparator
Arm Description
Norepinephrine Bitartrate Hydrate : 4 mg/4 mL
Arm Title
Phenylephrine
Arm Type
Active Comparator
Arm Description
Phenylephrine hydrochloride : 10 mg/1 mL
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Graft mean blood flow measured using transit time flowmetry
Description
Mean blood flow (in mL/min) of the graft vessel that was measured using transit time flowmetry
Time Frame
Intraoperative period
Title
Pulsatility of graft vessel measured using transit time flowmetry
Description
Pulsatility of graft vessel, which is presented as pulsatility index in unitless, that was measured using transit time flowmetry
Time Frame
Intraoperative period
Title
Diastolic filling of the graft vessel measured using transit time flowmetry
Description
Diastolic filling (in percentage) of the graft vessel that was measured using transit time flowmetry
Time Frame
Intraoperative period
Secondary Outcome Measure Information:
Title
Graft failure rate in patients received each vasopressor during surgery
Description
The rate of graft failure in patients received each vasopressor during surgery
Time Frame
Within seven days after surgery
Title
Capillary filling time in patients received each vasopressor during surgery
Description
Capillary filling time, which was measured by time to refill the capillary after compression, to evaluate the viability of the flap in patients received each vasopressor during surgery
Time Frame
Within seven days after surgery
Title
Skin necrosis rate in patients received each vasopressor during surgery
Description
The rate of skin necrosis, which is evaluated by any changes in skin color by description of the color of the skin by clinicians, to evaluate the viability of the graft in patients received each vasopressor during surgery
Time Frame
Within seven days after surgery
Title
Rate of vascular thrombosis in patients received each vasopressor during surgery
Description
The rate of arterial or venous complication by measure of skin color change or decrease in doppler flow or capillary refill to evaluate the viability of the graft in patients received each vasopressor during surgery
Time Frame
Within seven days after surgery
Title
Rate of wound infection or any wound problem in patients received each vasopressor during surgery
Description
The rate of any wound complication including infection to evaluate wound complication after surgery in patients each vasopressor during surgery
Time Frame
Within seven days after surgery
Title
Amount of transfusion in patients received each vasopressor during surgery
Description
Amount of transfusion to evaluate clinical outcomes in patients received each vasopressor during surgery
Time Frame
Within seven days after surgery
Title
Total amount of remifentanil infused during surgery in patients received each vasopressor
Description
The total amount of remifentanil infused during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
Time Frame
intraoperative period
Title
Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor
Description
The total amount of inotropic agents or vasopressor during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
Time Frame
intraoperative period
Title
Stroke volume during surgery in patients received each vasopressor
Description
Stroke volume (in mL) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Time Frame
intraoperative period
Title
Cardiac index during surgery in patients received each vasopressor
Description
Cardiac index (in L/min/m^2) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Time Frame
intraoperative period
Title
Stroke volume variation during surgery in patients received each vasopressor
Description
Stroke volume variation (in percentage) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
Time Frame
intraoperative period
Title
Serum lactate levels in patients received each vasopressor
Description
Serum lactate levels (in mmol/L) to evaluate the postoperative variables and clinical outcomes in patients received each vasopressor during surgery
Time Frame
Within seven days after surgery
Title
Wound exploration rate in patients received each vasopressor during surgery
Description
The rate of wound exploration as a measure of postoperative complication and graft failure to evaluate the flap outcome in patients received each vasopressor during surgery
Time Frame
Until discharge
Title
Reoperation rate in patients received each vasopressor during surgery
Description
The rate of reoperation as a measure of postoperative complication and graft failure to evaluate the flap outcome in patients received each vasopressor during surgery
Time Frame
Until discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Vasopressor on the Graft Blood Flow in TRAM

We'll reach out to this number within 24 hrs