Effects of Vasopressor on the Graft Blood Flow in TRAM

April 30, 2023 updated by: Youn Joung Cho, MD, PhD, Seoul National University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Norepinephrine
Norepinephrine Bitartrate Hydrate : 4 mg/4 mL
Drug: Norepinephrine
  • 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)
Active Comparator: Phenylephrine
Phenylephrine hydrochloride : 10 mg/1 mL
Drug: Phenylephrine
  • 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graft mean blood flow measured using transit time flowmetry
Time Frame: Intraoperative period
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
Time Frame: Intraoperative period
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
Time Frame: Intraoperative period
Diastolic filling (in percentage) of the graft vessel that was measured using transit time flowmetry
Intraoperative period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Graft failure rate in patients received each vasopressor during surgery
Time Frame: Within seven days after surgery
The rate of graft failure in patients received each vasopressor during surgery
Within seven days after surgery
Capillary filling time in patients received each vasopressor during surgery
Time Frame: Within seven days after 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
Within seven days after surgery
Skin necrosis rate in patients received each vasopressor during surgery
Time Frame: Within seven days after 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
Within seven days after surgery
Rate of vascular thrombosis in patients received each vasopressor during surgery
Time Frame: Within seven days after 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
Within seven days after surgery
Rate of wound infection or any wound problem in patients received each vasopressor during surgery
Time Frame: Within seven days after surgery
The rate of any wound complication including infection to evaluate wound complication after surgery in patients each vasopressor during surgery
Within seven days after surgery
Amount of transfusion in patients received each vasopressor during surgery
Time Frame: Within seven days after surgery
Amount of transfusion to evaluate clinical outcomes in patients received each vasopressor during surgery
Within seven days after surgery
Total amount of remifentanil infused during surgery in patients received each vasopressor
Time Frame: intraoperative period
The total amount of remifentanil infused during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
intraoperative period
Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor
Time Frame: intraoperative period
The total amount of inotropic agents or vasopressor during surgery to evaluate clinical outcomes and perioperative variables in patients received each vasopressor during surgery
intraoperative period
Stroke volume during surgery in patients received each vasopressor
Time Frame: intraoperative period
Stroke volume (in mL) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
intraoperative period
Cardiac index during surgery in patients received each vasopressor
Time Frame: intraoperative period
Cardiac index (in L/min/m^2) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
intraoperative period
Stroke volume variation during surgery in patients received each vasopressor
Time Frame: intraoperative period
Stroke volume variation (in percentage) measured by FlowTrac parameters to evaluate the intraoperative hemodynamics in patients received each vasopressor
intraoperative period
Serum lactate levels in patients received each vasopressor
Time Frame: Within seven days after surgery
Serum lactate levels (in mmol/L) to evaluate the postoperative variables and clinical outcomes in patients received each vasopressor during surgery
Within seven days after surgery
Wound exploration rate in patients received each vasopressor during surgery
Time Frame: Until discharge
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
Until discharge
Reoperation rate in patients received each vasopressor during surgery
Time Frame: Until discharge
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
Until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRAM_Vasopressor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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