Status:
COMPLETED
Improving Tissue Oxygenation in Breast Reconstruction Surgery
Lead Sponsor:
Dr. Glenio Mizubuti (MD, PhD)
Conditions:
Perioperative Tissue Oxygenation
Eligibility:
FEMALE
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Breast reconstruction is an integral part of breast cancer care. There are two main types of breast reconstruction: alloplastic (using implants), and autologous (using patient's tissue). The latter cr...
Detailed Description
The purpose of this trial is to evaluate the effects of perioperative hemodynamic therapy (guided by cardiac output monitoring) on tissue oxygenation during (and after) DIEP flap breast reconstruction...
Eligibility Criteria
Inclusion
- American Society of Anesthesiologists' (ASA) Physical Classification I-III;
- Undergoing elective unilateral or bilateral DIEP flap surgery;
- Competent to provide informed consent.
Exclusion
- Dementia or neurological impairment;
- Scheduled for DIEP flap combined with any other secondary surgical procedure;
- Documented left ventricular dysfunction (ejection fraction \< 40%);
- Contraindication to low-dose dobutamine;
- Body mass index \< 18 or \> 40 kg/m2;
- Pregnant or lactating;
- Renal insufficiency (eGFR \< 30 ml/min/1.73m2);
- Known liver insufficiency (i.e., documented cirrhosis, coagulopathy and/or encephalopathy of hepatic origin).
Key Trial Info
Start Date :
July 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04020172
Start Date
July 12 2019
End Date
May 1 2024
Last Update
August 5 2025
Active Locations (2)
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1
Kingston General Hospital
Kingston, Ontario, Canada, K7L2V7
2
Hotel Dieu Hospital
Kingston, Ontario, Canada