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Perioperative Management of DIEP Flaps

Sponsor
University of Regensburg (Other)
Overall Status
Unknown status
CT.gov ID
NCT03118024
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
23.6
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 13, 2017
Anticipated Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Mar 1, 2019

Arms and Interventions

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 Names:
  • Norephinephrine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Free flap survival rate [5 days postoperatively]

      Rates of (partial) flap loss in each study arm

    Secondary Outcome Measures

    1. Period of hospitalization [up to 14 days]

      Length of postoperative hospitalization in each study arm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital of Regensburg Regensburg Germany 93053

    Sponsors and Collaborators

    • University of Regensburg

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Alexandra Anker, Principal Investigator, University of Regensburg
    ClinicalTrials.gov Identifier:
    NCT03118024
    Other Study ID Numbers:
    • 16-101-0293
    First Posted:
    Apr 18, 2017
    Last Update Posted:
    Apr 18, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Alexandra Anker, Principal Investigator, University of Regensburg
    deep inferior epigastric perforator flap
    fluid restriction
    catecholamine restriction

    Study Results

    No Results Posted as of Apr 18, 2017