Blood FlowNCT05049278
Effects of Vasopressor on the Graft Blood Flow in TRAM
A study testing Norepinephrine and Phenylephrine in people with Blood Flow and Anastomotic Failure of Flap, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Blood Flow, Anastomotic Failure of Flap, Flap Necrosis
- What is being tested?
- Norepinephrine and Phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Sep 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Blood Flow, Anastomotic Failure of Flap, Flap Necrosis, Flap Ischemia
- Being tested
- Norepinephrine, Phenylephrine
- Keywords
- Blood flow, Failure of Flap, Vasopressor, Phenylephrine, Norepinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine | Active comparator | Norepinephrine Bitartrate Hydrate : 4 mg/4 mL Receives: Drug: Norepinephrine |
| Phenylephrine | Active comparator | Phenylephrine hydrochloride : 10 mg/1 mL Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Intraoperative period
Secondary outcomes (14)
Graft failure rate in patients received each vasopressor during surgery
The rate of graft failure in patients received each vasopressor during surgery
Measured: Within seven days after 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
Measured: Within seven days after 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
Measured: Within seven days after 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
Measured: Within seven days after 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
Measured: Within seven days after 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
Measured: Within seven days after 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
Measured: intraoperative period
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
Measured: intraoperative period
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
Measured: intraoperative period
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
Measured: intraoperative period
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
Measured: intraoperative period
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
Measured: Within seven days after 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
Measured: Until discharge
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
Measured: Until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start24 Sep 2021
- Primary completion23 Feb 2022
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood FlowStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049278
- Sponsor's protocol ID
- TRAM_Vasopressor
- Status last verified
- Apr 2023
- First submitted
- 4 Sep 2021
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05049278
- Acronym / sponsor ID
- TRAM_Vasopressor
- Conditions
- Blood Flow, Anastomotic Failure of Flap, Flap Necrosis, Flap Ischemia
- Keywords
- Blood flow, Failure of Flap, Vasopressor, Phenylephrine, Norepinephrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine | Active comparator | Drug: NorepinephrineNorepinephrine Bitartrate Hydrate : 4 mg/4 mL |
| Phenylephrine | Active comparator | Drug: PhenylephrinePhenylephrine hydrochloride : 10 mg/1 mL |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Norepinephrine |
| 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) | Drug | Phenylephrine |
Primary outcome
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
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
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
14 secondary outcomes
Graft failure rate in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Capillary filling time in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Skin necrosis rate in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Rate of vascular thrombosis in patients received each vasopressor during surgery
Time frame: 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
Amount of transfusion in patients received each vasopressor during surgery
Time frame: Within seven days after surgery
Total amount of remifentanil infused during surgery in patients received each vasopressor
Time frame: intraoperative period
Total amount of inotropic agents or vasopressor during surgery in patients received each vasopressor
Time frame: intraoperative period
Stroke volume during surgery in patients received each vasopressor
Time frame: intraoperative period
Cardiac index during surgery in patients received each vasopressor
Time frame: intraoperative period
Stroke volume variation during surgery in patients received each vasopressor
Time frame: intraoperative period
Serum lactate levels in patients received each vasopressor
Time frame: Within seven days after surgery
Wound exploration rate in patients received each vasopressor during surgery
Time frame: Until discharge
Reoperation rate in patients received each vasopressor during surgery
Time frame: Until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norepinephrine and Phenylephrine in people with Blood Flow and Anastomotic Failure of Flap, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft mean blood flow measured using transit time flowmetry (time frame: Intraoperative period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.