Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Total intraoperative fluid volume
研究概览
简要总结
Adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery requires maintaining blood pressure above 100 mmHg and avoiding excessive fluid administration. This study aims to determine whether the use of a measurement of preload dependency (Pulse Pressure Variation = PPV), can guide fluid therapy and if it decreases the risk of flap oedema. For this purpose, two fluid management strategies will be compared:
- Static intraoperative fluid management: Administration of crystalloid fluids is limited to 5ml/kg/h
- Dynamic intraoperative fluid management: Crystalloid fluids are only administered if PPV exceeds 12% The purpose of this study is to compare the static and dynamic (= targeted) fluid strategy and to evaluate the effect on flap oedema and flap perfusion.
详细描述
For adequate free flap perfusion during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction surgery, blood pressure must remain sufficiently high. General anaesthesia often induces systemic hypotension. To counteract this hypotension, the anaesthetist administers intravenous fluids (crystalloid fluids). However, fluid overload can lead to an increased risk of flap oedema and decreased flap perfusion and in exceptional cases to flap failure. To maintain blood pressure above 100 mmHg and to avoid excessive fluid administration, a vasopressor (norepinephrine) can be administered. This reduces the amount of fluids administered, thereby reducing the risk of flap oedema.
This study aims to determine whether the use of a measurement of preload dependency (Pulse Pressure Variation = PPV), can guide fluid therapy and if it decreases the risk of flap oedema. To this end, two fluid management strategies will be compared:
- Static intraoperative fluid management: Administration of crystalloid fluids is limited to 5ml/kg/h
- Dynamic intraoperative fluid management: Crystalloid fluids are only administered if PPV exceeds 12% The purpose of this study is to compare the static and dynamic (= targeted) fluid strategy and to evaluate the effect on flap oedema and flap perfusion.
All included patients are randomized in a 1:1 ratio to the static (n = 41) or dynamic group (n = 41).
To treat hypotension in patients randomized to the 'static' group, fluid administration is limited to 5 ml/kg/h. When the maximum fluid volume is administered but blood pressure remains below 100 mmHg, norepinephrine is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult patients, between 18 and 70 years of age
- •Patients scheduled for DIEP free flap breast reconstruction
- •Signed written informed consent form (ICF)
排除标准
- •present atrial fibrillation (AF)
- •heart failure New York Heart Association (NYHA) classification 2 or higher
- •chronic kidney disease (CKD) stage 3B or higher
- •American Society of Anesthesiologists (ASA) classification III or higher
- •known allergy to study specific medication
- •participation in another clinical trial
- •Inability of the patient to understand Dutch sufficiently
- •Patients who are pregnant or breastfeeding
研究组 & 干预措施
Static group
When during surgery systolic blood pressure (SBP) is below 100mmHg:
- give a fluid bolus (Plasmalyte A) until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg
- if the 5ml/kg/h crystalloid limit is already reached: start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min).
When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.
When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min: the anaesthetist can decide to give a bolus of 6mg ephedrine intravenous (IV) (with a maximum dose of 12mg ephedrine iv per hour).
干预措施: Plasma-lyte (static group) (Drug)
Static group
When during surgery systolic blood pressure (SBP) is below 100mmHg:
- give a fluid bolus (Plasmalyte A) until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg
- if the 5ml/kg/h crystalloid limit is already reached: start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min).
When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.
When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min: the anaesthetist can decide to give a bolus of 6mg ephedrine intravenous (IV) (with a maximum dose of 12mg ephedrine iv per hour).
干预措施: Norepinephrine (static group) (Drug)
Dynamic group
After insertion of an arterial line, a pulse contour analysis system will be installed (Acumen IQ sensor, Edwards) for measuring PPV and cardiac index (CI).
When during surgery SBP is below 100mmHg and PPV is above 12%:
• give a fluid bolus (Plasmalyte A) until PPV is below or equal to 12% or SBP is above 100mmHg
When during surgery SBP is below 100mmHg and PPV is below or equal to 12%:
• start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min) When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.
When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min, and CI is < 2.2 L/min/m², a bolus of 6mg ephedrine iv will be given (with a maximum dose of 12mg ephedrine iv per hour).
干预措施: Plasma-lyte (dynamic group) (Drug)
Dynamic group
After insertion of an arterial line, a pulse contour analysis system will be installed (Acumen IQ sensor, Edwards) for measuring PPV and cardiac index (CI).
When during surgery SBP is below 100mmHg and PPV is above 12%:
• give a fluid bolus (Plasmalyte A) until PPV is below or equal to 12% or SBP is above 100mmHg
When during surgery SBP is below 100mmHg and PPV is below or equal to 12%:
• start or increase norepinephrine infusion until SBP is above 100mmHg (with a maximum dose of 0.2mcg/kg/min) When SBP is above 120mmHg: decrease the norepinephrine infusion rate until SBP is below 120mmHg.
When SBP remains below 100mmHg after reaching a vasopressor dose of 0.2mcg/kg/min, and CI is < 2.2 L/min/m², a bolus of 6mg ephedrine iv will be given (with a maximum dose of 12mg ephedrine iv per hour).
干预措施: Norepinephrine (dynamic group) (Drug)
结局指标
主要结局
Total intraoperative fluid volume
时间窗: From anaesthesia induction until completed skin closure, assessed up to 12 hours
Total intraoperative fluid volume (from anaesthesia induction until completed skin closure)
次要结局
- Percentage of time Systolic Blood Pressure (SBP) was above 100mmHg(During surgery, from anaesthesia induction until completed skin closure, assessed up to 12 hours)
- Length of stay(From ICU admission until ICU/ PACU discharge, assessed up to 60 hours)
- Peri- and postoperative blood lactate levels(From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours)
- Cumulative perioperative fluid volume(From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours)
- Surgical complications(At ICU/ PACU discharge, assessed up to 60 hours and at hospital discharge, assessed up to 2 weeks)
- Cumulative perioperative norepinephrine dose(From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours)
- Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry)(From ICU admission until ICU/ PACU discharge, assessed up to 60 hours)
研究者
Silvie Allaert
Principal Investigator
Algemeen Ziekenhuis Maria Middelares