Perioperative Management of DIEP Flaps

University of Regensburg (UR)

Status: Unknown

Conditions: Microsurgery; Mammaplasty; Free Tissue Flaps

Treatments: Drug: Crystalloid Solutions; Drug: Catecholamines

Study type: Interventional

Funder types: Other

Identifiers

NCT03118024

16-101-0293

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Fluid restriction

Active Comparator group

Description:

Crystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min

Treatment:

Drug: Crystalloid Solutions

Catecholamine restriction

Active Comparator group

Description:

Noradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h

Treatment:

Drug: Catecholamines