Perioperative Management of DIEP Flaps

Not Applicable

• Conditions: Mammaplasty; Microsurgery; Free Tissue Flaps
• Interventions: Drug: Crystalloid Solutions; Drug: Catecholamines

• Registration Number: NCT03118024
• Lead Sponsor: University of Regensburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-13
• Study First Submitted: 2017-03-25
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-12
• Study First Posted: 2017-04-18
• Last Update Posted: 2017-04-18
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid restriction	Crystalloid Solutions	Crystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min
Catecholamine restriction	Catecholamines	Noradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h

Primary Outcome Measures

Name	Time	Method
Free flap survival rate	5 days postoperatively	Rates of (partial) flap loss in each study arm

Secondary Outcome Measures

Name	Time	Method
Period of hospitalization	up to 14 days	Length of postoperative hospitalization in each study arm

Trial Locations

Locations (1)

University hospital of Regensburg; 🇩🇪 Regensburg, Germany