2024-517699-39-00招募中3 期
Prolonged corticosteroid therapy in scheduled cardiac surgery in intermediate/high-risk patients: a prospective multicenter randomized controlled double-blind placebo-controlled study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 3
- 主要终点
- The primary endpoint is a composite of the occurrence within 7 days of surgery of one of the following 3 events: - Acute renal failure (ARF). - Occurrence of a postoperative pulmonary complication (PPC). - Use of noradrenaline.
研究概览
简要总结
demonstrate the efficacy of prolonged corticosteroid therapy for 5 days (Hydrocortisone + Fludrocortisone) versus placebo in intermediate/high-risk patients undergoing scheduled cardiac surgery.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Patient at intermediate/high risk (Euroscore II>4%)
- •Patient admitted for scheduled cardiac surgery
- •Extracorporeal circulation
- •signed informed consent
排除标准
- •Endocarditis
- •End-stage renal failure with long-term dialysis
- •Contraindications to the administration of hydrocortisone and/or fludrocortisone according to the drugs' prescribing information
- •Pregnant or breast-feeding women
- •Patients under guardianship, curatorship or safeguard of justice
- •Beating heart surgery
- •Heart transplantation or long-term ventricular assistance
- •Emergency surgery: aortic dissection, emergency coronary artery bypass surgery
- •Failed exit from bypass with need for short-acting assistance (counterpulsation balloon, ECMO)
- •Hypothermic surgery
- •Previous cardiac surgery
- •Patient on long-term corticosteroid therapy
- •Autoimmune or chronic inflammatory disease.
结局指标
主要结局
The primary endpoint is a composite of the occurrence within 7 days of surgery of one of the following 3 events: - Acute renal failure (ARF). - Occurrence of a postoperative pulmonary complication (PPC). - Use of noradrenaline.
The primary endpoint is a composite of the occurrence within 7 days of surgery of one of the following 3 events: - Acute renal failure (ARF). - Occurrence of a postoperative pulmonary complication (PPC). - Use of noradrenaline.
次要结局
- Major cardiac events (MCE)
- Stroke will be defined by the sudden onset of neurological deficit and confirmed by brain imaging.
- The total quantity of noradrenaline will be expressed in mg and will correspond to the dose received from admission to intensive care until day 7 after surgery.
- The side-effects of interest are as follows: Hypernatremia defined by a natraemia > 145 mmol/l. Hyperglycemia defined by the need for insulin therapy. One of the following infections: urinary tract infection, postoperative pneumonitis, mediastinitis.
- Mortality at 28 days is defined as death from any cause from the date of surgery up to and including day 28.
研究者
Beyls Christophe
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (3)
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