Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy
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: sodium bicarbonate Ringer's solution.
- Кому может быть актуально
- Состояния в реестре: Hepatic Ischemia. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- 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
The Application of Sodium Bicarbonate Ringer's Solution on Perioperative Lactic Acid Concentration and Early Recovery Quality in Patients Undergoing Laparoscopic Hepatectomy
Обзор
Compared the effects of Sodium bicarbonate Ringer's solution and lactate Ringer's solution on the internal environment and hemodynamics of patients during laparoscopic liver resection, to observe the application prospect of sodium bicarbonate Ringer's solution in Laparoscopic hepatectomy.
Подробное описание
The study was a single-center prospective randomized controlled study. A total of 100 patients undergoing laparoscopic hepatectomy under general anesthesia were randomly divided into 2 groups: Group A, sodium bicarbonate Ringer's solution group(n=50); Group B, Lactate Ringer's solution group (intraoperative crystal fluid dilatation was lactate ringer's injection, n=50); Collect patients' arterial blood gas, blood pressure, heart rate, peripheral vascular resistance, heart rate, blood vessels, the active drug usage, 5% sodium bicarbonate injection usage, inflammation factors, transaminase, creatinine, etc. with the point of preoperative (T0), during liver specimens resected(T1), after liver specimens resected(T2), and the end of surgery (T3). Then statistical analysis and observe the application prospect of sodium bicarbonate Ringer's injection in Laparoscopic hepatectomy.
Вмешательства
- Препарат sodium bicarbonate Ringer's solution
Sodium bicarbonate Ringer's solution was used in Group A as intraoperative intravenous fluids. Lactate Ringer's solution was used in Group B as intraoperative intravenous fluids.
Первичные конечные точки
- lactic values [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.]
Вторичные конечные точки (12)
- Amount of sodium bicarbonate injection (ml) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 month.]
- Value of pH [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Concentration of HCO3- [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Value of BE [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Concentration of Glucose [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Value of MAP [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Value of HR [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Concentration of CI [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Value of SVV [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Value of SVR [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Value of PPV [Срок оценки: From the start of operation until the end of operation (during the operation).]
- Amount of norepinephrine [Срок оценки: From the start of operation until the end of operation (during the operation).]
Критерии участия
Критерии включения
- ≥18 years old,
- patients who plan to undergoing laparoscopic hepatectomy ;
- Willing to sign informed consent.
Критерии исключения
- age <18 years
- pregnancy
- active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
- history of significant cerebrovascular disease
- restrictive or obstructive pulmonary disease
- uncontrolled hypertension
- renal dysfunction (glomerular filtration rate <60 mL/min),
- evidence of hepatic metabolic disorder (bilirubin >35 mmol/L)
- presence of active infection
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Shijiang Liu — Нанкин
Идентификаторы
NCT: NCT05830136 · 2021-SR-386