Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Plasma-lyte (static group), Norepinephrine (static group), Plasma-lyte (dynamic group), Norepinephrine (dynamic group).
- Кому может быть актуально
- Состояния в реестре: Hypotension During Surgery. Базовые параметры: 18 лет — 70 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Goal-directed Fluid Therapy During Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction - a Randomised Controlled Trial
Обзор
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.
Подробное описание
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.
Treatment of hypotension in patients randomized to the 'dynamic' (= targeted fluid therapy) group, is guided by PPV. PPV is measured continuously during the surgery and if the blood pressure is below 100 mmHg, fluids are only administered if PPV is \> 12%. If blood pressure is below 100 mmHg but PPV is \< 12% (indicating no fluid is needed), norepinephrine is administered.
At the end of the procedure, 2 sensors are applied, these sensors provide information about the perfusion of the free flap during patient's stay in Intensive Care or the recovery room.
Вмешательства
- Препарат Plasma-lyte (static group)
Plasmalyte will be administered intravenously: (1) as a maintenance infusion 1ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until 5ml/kg/h crystalloid (without maintenance infusion) is reached or until SBP is above 100mmHg - Препарат Norepinephrine (static group)
When during surgery SBP is below 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). - Препарат Plasma-lyte (dynamic group)
Plasmalyte will be administered intravenously: (1) as a maintenance infusion 1 ml/kg/h (from anaesthesia induction until ICU/PACU discharge); (2) as a fluid bolus until PPV is below or equal to 12% or SBP is above 100mmHg. - Препарат Norepinephrine (dynamic group)
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.
Первичные конечные точки
- Total intraoperative fluid volume [Срок оценки: From anaesthesia induction until completed skin closure, assessed up to 12 hours]
Вторичные конечные точки (7)
- Cumulative perioperative fluid volume [Срок оценки: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours]
- Cumulative perioperative norepinephrine dose [Срок оценки: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours]
- Peri- and postoperative blood lactate levels [Срок оценки: From anaesthesia induction until ICU/ PACU discharge, assessed up to 72 hours]
- Percentage of time Systolic Blood Pressure (SBP) was above 100mmHg [Срок оценки: During surgery, from anaesthesia induction until completed skin closure, assessed up to 12 hours]
- Postoperative free flap tissue oxygenation and blood perfusion (tissue oximetry) [Срок оценки: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours]
- Surgical complications [Срок оценки: At ICU/ PACU discharge, assessed up to 60 hours and at hospital discharge, assessed up to 2 weeks]
- Length of stay [Срок оценки: From ICU admission until ICU/ PACU discharge, assessed up to 60 hours]
Критерии участия
Критерии включения
- Female adult patients, between 18 and 70 years of age
- Patients scheduled for DIEP free flap breast reconstruction
- Signed written informed consent form (ICF)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Бельгия · 1 центр
- AZ Maria Middelares — Ghent
Идентификаторы
NCT: NCT06080178 · MMS.2023.036