Perioperative Management of DIEP Flaps

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mammaplasty Microsurgery Free Tissue Flaps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fluid restriction

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

Group Type ACTIVE_COMPARATOR

Crystalloid Solutions

Intervention Type DRUG

crystalloid restrictive anesthesia protocol

Catecholamine restriction

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

Group Type ACTIVE_COMPARATOR

Catecholamines

Intervention Type DRUG

catecholamine restrictive anesthesia protocol

Interventions

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Crystalloid Solutions

crystalloid restrictive anesthesia protocol

Intervention Type DRUG

Catecholamines

catecholamine restrictive anesthesia protocol

Intervention Type DRUG

Other Intervention Names

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Norephinephrine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes