MammaplastyNCT03118024
Perioperative Management of DIEP Flaps
A study testing Crystalloid Solutions and Catecholamines in people with Mammaplasty and Microsurgery, run by University of Regensburg at 1 site in Germany.
Trial summary
By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammaplasty, Microsurgery, Free Tissue Flaps
- What is being tested?
- Crystalloid Solutions and Catecholamines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 13 Mar 2017to Mar 2019
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent for study participation
- Every patient undergoing breast reconstruction (primary and secondary reconstruction) with deep inferior epigastric perforator flap at our hospital is offered to participate in the study
Who cannot join
- No informed consent for study participation
- Patients with a high thromboembolic risk profile
- During pregnancy and breastfeeding
- Minors
- Patients with a health care proxy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University hospital of Regensburg
Regensburg, 93053
Anker Alexandra, MD, 0049 941 782 3110, aanker@caritasstjosef.de
About this study
Official title: Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction
By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.
- Conditions
- Mammaplasty, Microsurgery, Free Tissue Flaps
- Being tested
- Crystalloid Solutions, Catecholamines
- Keywords
- deep inferior epigastric perforator flap, fluid restriction, catecholamine restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalloid SolutionsDrug
crystalloid restrictive anesthesia protocol
CatecholaminesDrug
Also called Norephinephrine
catecholamine restrictive anesthesia protocol
| Study group | Role | What they receive |
|---|---|---|
| Fluid restriction | Active comparator | Crystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min Receives: Drug: Crystalloid Solutions |
| Catecholamine restriction | Active comparator | Noradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h Receives: Drug: Catecholamines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free flap survival rate
Rates of (partial) flap loss in each study arm
Measured: 5 days postoperatively
Secondary outcomes (1)
Period of hospitalization
Length of postoperative hospitalization in each study arm
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start13 Mar 2017
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alexandra Anker, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118024
- Sponsor's protocol ID
- 16-101-0293
- Status last verified
- Apr 2017
- First submitted
- 25 Mar 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-570. doi: 10.1097/PRS.0b013e31825dbf73.
PubMed 22929242Motakef S, Mountziaris PM, Ismail IK, Agag RL, Patel A. Emerging paradigms in perioperative management for microsurgical free tissue transfer: review of the literature and evidence-based guidelines. Plast Reconstr Surg. 2015 Jan;135(1):290-299. doi: 10.1097/PRS.0000000000000839.
PubMed 25539313
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03118024
- Acronym / sponsor ID
- 16-101-0293
- Conditions
- Mammaplasty, Microsurgery, Free Tissue Flaps
- Keywords
- deep inferior epigastric perforator flap, fluid restriction, catecholamine restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Apr 2017 (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.
By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluid restriction | Active comparator | Drug: Crystalloid SolutionsCrystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min |
| Catecholamine restriction | Active comparator | Drug: CatecholaminesNoradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent for study participation
- Every patient undergoing breast reconstruction (primary and secondary reconstruction) with deep inferior epigastric perforator flap at our hospital is offered to participate in the study
Key exclusion criteria (5 listed)
- No informed consent for study participation
- Patients with a high thromboembolic risk profile
- During pregnancy and breastfeeding
- Minors
- Patients with a health care proxy
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 |
|---|---|---|
| Crystalloid Solutionscrystalloid restrictive anesthesia protocol | Drug | Fluid restriction |
| CatecholaminesAlso: Norephinephrinecatecholamine restrictive anesthesia protocol | Drug | Catecholamine restriction |
Primary outcome
Free flap survival rate
Time frame: 5 days postoperatively
Rates of (partial) flap loss in each study arm
1 secondary outcome
Period of hospitalization
Time frame: up to 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Background: PubMed 22929242Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-570. doi: 10.1097/PRS.0b013e31825dbf73.
- Background: PubMed 25539313Motakef S, Mountziaris PM, Ismail IK, Agag RL, Patel A. Emerging paradigms in perioperative management for microsurgical free tissue transfer: review of the literature and evidence-based guidelines. Plast Reconstr Surg. 2015 Jan;135(1):290-299. doi: 10.1097/PRS.0000000000000839.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystalloid Solutions and Catecholamines in people with Mammaplasty and Microsurgery, run by University of Regensburg at 1 site in Germany.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Apr 2017. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Anker, MD (0049 941 782 3110, aanker@caritasstjosef.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free flap survival rate (time frame: 5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118024, which also lists 2 linked publications.
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 18 Apr 2017.