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Perioperative Management of DIEP Flaps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118024
Recruitment Status : Unknown
Verified April 2017 by Dr. Alexandra Anker, University of Regensburg.
Recruitment status was:  Recruiting
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Alexandra Anker, 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.

Condition or disease Intervention/treatment Phase
Mammaplasty Microsurgery Free Tissue Flaps Drug: Crystalloid Solutions Drug: Catecholamines Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fluid restriction
Crystalloid fluid max. 2.0 ml/kg/h, no administration of colloids, noradrenaline max. 0.15 µg/kg/min
Drug: Crystalloid Solutions
crystalloid restrictive anesthesia protocol

Active Comparator: Catecholamine restriction
Noradrenaline max. 0.04 µg/kg/min, fluids max. 8.0 ml/kg/h
Drug: Catecholamines
catecholamine restrictive anesthesia protocol
Other Name: Norephinephrine




Primary Outcome Measures :
  1. Free flap survival rate [ Time Frame: 5 days postoperatively ]
    Rates of (partial) flap loss in each study arm


Secondary Outcome Measures :
  1. Period of hospitalization [ Time Frame: up to 14 days ]
    Length of postoperative hospitalization in each study arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118024


Contacts
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Contact: Alexandra Anker, MD 0049 941 782 3110 aanker@caritasstjosef.de

Locations
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Germany
University hospital of Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Anker Alexandra, MD    0049 941 782 3110    aanker@caritasstjosef.de   
Sponsors and Collaborators
University of Regensburg
Publications:
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Responsible Party: Dr. Alexandra Anker, Principal Investigator, University of Regensburg
ClinicalTrials.gov Identifier: NCT03118024    
Other Study ID Numbers: 16-101-0293
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Alexandra Anker, University of Regensburg:
deep inferior epigastric perforator flap
fluid restriction
catecholamine restriction