Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery

Официальное название

Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery: a Randomized and Prospective Clinical Trial

Обзор

The purpose of this study is evaluate goal-directed therapy with continuous central venous saturation compared to standard therapy in children undergoing cardiac surgery.

Подробное описание

Pediatric patients undergoing cardiac surgery are at risk for adverse clinical outcomes due a inadequate tissue perfusion. Recent studies have been demonstraded which the monitorization of continuos central venous saturation could be benneficial. There is evidence that monitoring continues venous oxygen saturation (ScvO2) can be beneficial in patient outcomes, guided by ScvO2 therapy has been associated with improved outcomes in resuscitation of critically ill patients with sepsis and after congenital heart surgery complexa. The early detection and treatment of tissue hypoxia can prevent morbidity and mortality. tissue hypoxia may be a result of the imbalance between supply (DO2) and oxygen consumption (VO2). If the fault supply, oxygen consumption is maintained by increased oxygen extraction resulting in decreased central venous oxygen saturation

Вмешательства

• Другое Continuous central venous oxygenation monitoring
  Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic. * First, isotonic crystalloid, 10 up to 20 mL/kg, will be administered in boluses to achieve continuous central venous oxygen saturation higher than 65% in non-cyanogenic and 55% in cyanogenic. * Second, if not achieved with fluid administration, will be targeted by initiating and titrating inotropics (dobutamine or milrinone). If the mean arterial pressure is lower than 50 mm Hg
• Другое Standard protocol
  The control group will keep the standard therapy to achieve mean arterial pressure higher than 50mmHg, central venous pressure 8 to 12 mmHg, urinay debit higher than 0,5ml/kg/h, hemoglobin higher or equal than 8g/dL, arterial oxygen saturation higher or equal than 92% in non-cyanogenic and 80% cyanogenic, central venous oxygen saturation higher or equal than 65% in non-cyanogenic and 55% in cyanogenic.

Первичные конечные точки

• Lactate clearance [Срок оценки: at the beginning of surgery up to 24 hours after surgery]

Вторичные конечные точки (7)

• Length of Mechanical ventilation [Срок оценки: within 30 days after cardiac surgery]
• Vasopressors and inotropic therapy [Срок оценки: within 30 days after cardiac surgery]
• Cardiac complications [Срок оценки: within 30 days after cardiac surgery]
• Renal complications [Срок оценки: within 30 days after cardiac surgery]
• Infection [Срок оценки: within 30 days after cardiac surgery]
• Length of ICU stay [Срок оценки: within 30 days after cardiac surgery]
• Length of hospital stay [Срок оценки: within 30 days after cardiac surgery]

Критерии участия

Критерии включения

• Elective cardiac surgery with cardiopulmonary bypass
• Written informed consent

Критерии исключения

• Cardiac arrhythmia
• Emergency operation
• Hemodynamic instabillty (norepinephrine higher than 1 mcg/kg/min)
• Neoplasia
• Heart transplant
• Participation in another study

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Incor - Heart Institute - University of Sao Paulo — São Paulo

Идентификаторы

NCT: NCT03469440 · 3988.13.113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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