Effects of Vasopressor on the Graft Blood Flow in TRAM

Blood Flow Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049278
• Other study ID #: TRAM_Vasopressor
• Status: Completed
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: February 23, 2023

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Flow
• Flap Ischemia
• Flap Necrosis
• Ischemia
• Necrosis

Intervention

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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Graft failure rate in patients received each vasopressor during surgery	The rate of graft failure in patients received each vasopressor during surgery	Within seven days after surgery
Secondary	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	Within seven days after surgery
Secondary	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	Within seven days after surgery
Secondary	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	Within seven days after surgery
Secondary	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	Within seven days after surgery
Secondary	Amount of transfusion in patients received each vasopressor during surgery	Amount of transfusion to evaluate clinical outcomes in patients received each vasopressor during surgery	Within seven days after surgery
Secondary	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	intraoperative period
Secondary	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	intraoperative period
Secondary	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	intraoperative period
Secondary	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	intraoperative period
Secondary	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	intraoperative period
Secondary	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	Within seven days after surgery
Secondary	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	Until discharge
Secondary	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	Until discharge