Perioperative Management of DIEP Flaps
Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction
1 other identifier
interventional
100
1 country
1
Brief 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 deep inferior epigastric artery flaps for breast reconstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2017
CompletedFirst Submitted
Initial submission to the registry
March 25, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedApril 18, 2017
April 1, 2017
2 years
March 25, 2017
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Free flap survival rate
Rates of (partial) flap loss in each study arm
5 days postoperatively
Secondary Outcomes (1)
Period of hospitalization
up to 14 days
Study Arms (2)
Fluid restriction
ACTIVE COMPARATORCrystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min
Catecholamine restriction
ACTIVE COMPARATORNoradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h
Interventions
catecholamine restrictive anesthesia protocol
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- No informed consent for study participation
- Patients with a high thromboembolic risk profile
- During pregnancy and breastfeeding
- Minors
- Patients with a health care proxy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital of Regensburg
Regensburg, 93053, Germany
Related Publications (2)
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.
PMID: 22929242BACKGROUNDMotakef 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.
PMID: 25539313BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 25, 2017
First Posted
April 18, 2017
Study Start
March 13, 2017
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
April 18, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share