Improving oxygen levels in breast reconstruction surgery

Can Dobutamine and Goal-Directed Fluid Therapy Improve Tissue Oxygenation in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction Surgery? Randomized Controlled Trial

This study is testing whether a special treatment during breast reconstruction surgery can improve oxygen levels in the tissue to help with healing.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Queen's University (other)
• Locations: 2 sites (Kingston, Ontario and 1 other locations)
• Trial ID: NCT04020172 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effects of perioperative hemodynamic therapy on tissue oxygenation during DIEP flap breast reconstruction surgery. Patients will be randomly assigned to receive a combination of cardiac output-guided fluid therapy and low-dose dobutamine infusion. The primary outcome is to measure tissue oxygenation using near-infrared spectroscopy after the surgical procedure. Secondary outcomes include monitoring fluid administration, the need for surgical re-intervention, and various laboratory measures.

Who should consider this trial

Good fit: Ideal candidates are patients classified as ASA Physical Classification I-III who are undergoing elective unilateral or bilateral DIEP flap surgery.

Not a fit: Patients with documented left ventricular dysfunction, severe obesity or underweight, or those with contraindications to dobutamine may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce complications related to poor flap perfusion in breast reconstruction surgery.

How similar studies have performed: Other studies have shown promising results with similar approaches to improving tissue perfusion in surgical settings.

Eligibility criteria

Inclusion Criteria:

* American Society of Anesthesiologists' (ASA) Physical Classification I-III;
* Undergoing elective unilateral or bilateral 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 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).

Where this trial is running

Kingston, Ontario and 1 other locations

• Kingston General Hospital — Kingston, Ontario, Canada (RECRUITING)
• Hotel Dieu Hospital — Kingston, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Glenio B. Mizubuti, MD, MSc, FRCPC — Queen's University - Anesthesiology
• Study coordinator: Glenio B. Mizubuti, MD, MSc, FRCPC

Conditions: Perioperative Tissue Oxygenation, tissue flap oxygenation, DIEP flap breast reconstruction surgery