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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03118024
Other study ID # 16-101-0293
Secondary ID
Status Recruiting
Phase N/A
First received March 25, 2017
Last updated April 12, 2017
Start date March 13, 2017
Est. completion date March 2019

Study information

Verified date April 2017
Source University of Regensburg
Contact Alexandra Anker, MD
Phone 0049 941 782 3110
Email aanker@caritasstjosef.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Crystalloid Solutions
crystalloid restrictive anesthesia protocol
Catecholamines
catecholamine restrictive anesthesia protocol

Locations

Country Name City State
Germany University hospital of Regensburg Regensburg

Sponsors (1)

Lead Sponsor Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-70. doi: 10.1097/PRS.0b013e31825dbf73. — View Citation

Motakef S, Mountziaris PM, Ismail IK, Agag RL, Patel A. Emerging paradigms in perioperative management for microsurgical free tissue transfer: review of the literature and evidence-based guidelines. Plast Reconstr Surg. 2015 Jan;135(1):290-9. doi: 10.1097/PRS.0000000000000839. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Free flap survival rate Rates of (partial) flap loss in each study arm 5 days postoperatively
Secondary Period of hospitalization Length of postoperative hospitalization in each study arm up to 14 days
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