2024-515998-94-00招募中3 期
GLORIOUS II: Dexamethasone, olanzapine, flow-targeted versus pressure-targeted hemodynamic management, and low tidal volume ventilation in patients undergoing on-pump cardiac surgery – a multifactorial design randomized trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- The primary endpoint will be number of days alive and outside hospital within 90 days after surgery.
研究概览
简要总结
The primary objective of this trial is to determine the efficacy of dexamethasone compared with placebo on the primary endpoint days alive outside hospital within 90 days in adult subjects undergoing elective or subacute isolated CABG, isolated AVR, or CABG plus any concomitant valve surgery. The coprimary objectives are to determine the efficacy of olanzapine versus placebo administered preoperatively, the efficacy of flow-targeted versus pressure-targeted hemodynamic management during CPB, and the efficacy of low tidal volume ventilation versus no ventilation during CPB, on the endpoint days alive outside hospital within 90 days in adult subjects undergoing elective or subacute isolated CABG, isolated AVR, or CABG plus any concomitant valve surgery.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult, i.e., above 18 years of age
- •Scheduled for CABG and/or AVR, irrespective of other concomitant valve surgery.
排除标准
- •Acute surgery (i.e. off hours surgery)
- •Previous participation in the trial
- •Active infection, including bacterial, viral, and/or fungal infection
- •Known hepatic cirrhosis
- •Known severe thrombocytopenia with thrombocyte levels < 50 x 109/L
- •Known severe neutropenia with neutrocyte levels < 2 x 109/L
- •On the waiting list for a heart transplant
- •Type I diabetes
- •Known long QT syndrome
- •Known allergy for any of the included study drugs
- •Any condition, where participation in the study, in the investigator's opinion could put the subject at risk, confound the study results or interfere significantly with participation in the study
- •Recipient of any major organ transplant
- •Patients with extracardiac arteriopathy (assessed as part of the preoperative EuroSCORE) will be excluded from the intervention 'flowtargeted vs. pressure-targeted hemodynamic management during CPB'.
- •Obstructive hypertrophic cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism
- •Having received cytotoxic/cytostatic chemotherapy or radiation therapy for treatment of malignancy within the last 6 months
- •Clinical evidence of current malignancy except for basal or localized squamous cell carcinoma, cervical intraepithelial neoplasia or stable prostate cancer.
- •Known narrow-angle glaucoma
- •Known phenylketonuria
- •Pregnancy or currently breastfeeding
- •Known endocarditis at time of screening
结局指标
主要结局
The primary endpoint will be number of days alive and outside hospital within 90 days after surgery.
The primary endpoint will be number of days alive and outside hospital within 90 days after surgery.
次要结局
- Time in days to occurrence of any component in a composite secondary endpoint during follow-up: a) Death from any cause, b) Stroke, c) Acute kidney injury or d) New onset or worsening heart failure
- Severe post-operative complications during index admission, defined as a Clavien-Dindo class of 3 to 5.
- Delirium during the first 7 days after surgery, defined as a positive Confusion Assessment Method for the ICU (CAM-ICU) score or a positive Confusion Assessment Method (CAM) score for the general wards
- Quality of Recovery-15 (QoR-15) score 3 days, or as soon as possible, after surgery
- 90-day outcomes: Survival, Change in modified Rankin Scale (mRS) from baseline, Health-related quality of life (EQ-5D-5L), Change in self-perceived function "two simple questions" and Days alive outside ICU
- 180-day outcomes: Survival
研究者
Christian Hingstrup Hassager
Scientific
Rigshospitalet
研究点 (2)
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