Can Dobutamine and Goal-Directed Fluid Therapy Improve Tissue Oxygenation in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction Surgery? Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Tissue Flap Oxygenation
研究概览
简要总结
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, however, do occur with DIEP flap surgery and 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 via near-infrared spectroscopy in all patients for up to 48 hours postoperatively. Optimal fluid therapy in combination with dobutamine may improve flap oxygenation and thereby, reduce complications.
详细描述
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 surgery. We hypothesize that a low-dose, perioperative dobutamine infusion combined with goal-directed fluid therapy guided by cardiac output monitoring will improve flap perfusion (and, thus, oxygenation) in patients undergoing DIEP surgery.
The primary outcome is tissue oxygenation, measured via near-infrared spectroscopy (NIRS), 45 minutes following vascular re-anastomosis of the DIEP flap within the perfusion zone that is furthest away from the perforator vessels. This zone is the most vulnerable surgical area to ischemia and, therefore, the most likely to reflect the potential benefits of the proposed intervention. In the case of bilateral DIEP flaps, the most vulnerable zone will be assessed in both the left and right breasts.
Secondary outcomes include: (1) tissue oxygenation at baseline (preoperatively), intra-operatively, 1, 2, 4, 8 hours postoperatively, as well as the morning of postoperative days 1 and 2; (2) the amount of intravenous fluids (crystalloids, colloids, blood products) and vasopressors (e.g., phenylephrine, ephedrine, norepinephrine, etc.) administered intraoperatively and up to 4 hours postoperatively; (3) the need for intraoperative surgical vascular re-intervention (i.e., re-anastomosis); (4) laboratory measures including perioperative pH, serum lactate, and hemoglobin measures; (5) the incidence of postoperative nausea and vomiting (PONV); (6) hospital length of stay; (7) any postoperative complications including infection, hematoma and those resulting from flap mal-perfusion (i.e., partial/total flap loss and/or fat necrosis); (8) the need for postoperative intervention for flap-related issues; (9) overall patient satisfaction; and (10) days alive and out of hospital (DAOH) all up until 30 days postoperatively.
Study Design and Duration:
This is a prospective, randomized controlled trial. Forty participants will be randomized to one of two groups (n=20/group) using computer-generated randomization. Patient randomization will be concealed in envelopes and opened only by research staff (not otherwise involved with data collection) and/or the attending anesthesiologist prior to anesthesia induction. Blinding will be maintained until study completion (n=20/group) and verification that all outcome data has been successfully collected for all study participants. Each participant will be monitored perioperatively until postoperative day 2 (or until discharge from hospital) and will receive a 30 day follow-up telephone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists' (ASA) Physical Classification I-III;
- •Undergoing elective unilateral or bilateral DIEP flap surgery;
- •Competent to provide informed consent.
排除标准
- •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).
研究组 & 干预措施
Dobutamine + Goal-Directed Fluid Therapy
All patients will receive a baseline infusion of Ringer's lactate at 2 ml/kg/h to satisfy maintenance fluid requirements. The intervention will commence at anesthesia induction and continue for up to 4 hours postoperatively. In addition to maintenance fluids, patients will receive 250 ml fluid challenges with crystalloid as required until they are no longer fluid responsive. The absence of fluid responsiveness will be defined as the absence of a sustained rise in stroke volume index of at least 10% for 20 minutes or more, at which point, the patient will be considered fluid optimized. At this point, a low-dose dobutamine infusion at a fixed rate (2.5 μg/kg/min) will be commenced and maintained until 4 hours postoperatively. The infusion rate will be halved and/or discontinued if the patient develops tachycardia (heart rate ≥ 100 bpm) for more than 30 minutes despite adequate anesthesia/analgesia and fluid status.
干预措施: Dobutamine (Drug)
结局指标
主要结局
Tissue Flap Oxygenation
时间窗: 45 min following vascular re-anastomosis
Tissue oxygenation of the breast flap tissue (measured via near-infrared spectroscopy, NIRS), 45 minutes following vascular re-anastomosis of the DIEP flap within the perfusion zone that is furthest away from the perforator vessels.
次要结局
- Tissue Flap Oxygenation(Immediately preoperatively until up to 48 hours postoperatively)
- Complications Associated with Flap Mal-Perfusion(Immediately postoperatively until 30 days postoperatively)
- DAOH(From date and time of discharge from hospital to 30 days postoperatively)
- Other Complications(Immediately postoperatively up until 30 days postoperatively)
- Intravenous Fluids(Immediately preoperatively until up to 48 hours postoperatively)
- Hospital Length of Stay(From date and time of end of surgery until the date and time of discharge from hospital or up to 30 days postoperatively (whichever comes first).)
- Patient Satisfaction(Immediately postoperatively until 30 days postoperatively)
研究者
Dr. Glenio Mizubuti (MD, PhD)
Dr. Glenio Mizubuti (MD, MSc, FRCPC), Anesthesiologist
Queen's University