Improving Tissue Oxygenation in Breast Reconstruction Surgery

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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 creates a more natural breast mound, and avoids long-term concerns requiring surgical re-intervention associated with implant-based surgery. The deep inferior epigastric perforator (DIEP) flap is the gold standard technique in autologous breast reconstruction. Complications that do occur with DIEP flap surgery often stem from poor flap perfusion/oxygenation. Hence, the development of strategies to enhance flap perfusion (e.g., optimal perioperative fluid therapy) is essential. Current perioperative fluid therapy is usually guided by subjective criteria which leads to wide variations in fluids administered. We will randomly assign DIEP flap patients to receive optimal (cardiac output-guided) fluid therapy in combination with dobutamine (a medication which has potential to improve flap oxygenation) versus the current standard of care. Flap oxygenation will be monitored in all patients for up to 48 hours postoperatively. Optimal fluid therapy in combination with dobutamine may improve flap oxygenation and thereby, reduce complications.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Treatments: Dobutamine

Criteria

Inclusion Criteria:

• ASA I-III

• Undergoing elective DIEP flap surgery

• Competent to provide informed consent

Exclusion Criteria:

• 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

• Pregnant or lactating

• Renal insufficiency (eGFR < 30)

• Known liver insufficiency (i.e., documented cirrhosis, coagulopathy and/or encephalopathy of hepatic origin)