2023-510561-10-00招募中2 期
Antioxidant Treatment with Vitamin C in Cardiac Surgery Patients – A Pilot Randomized Controlled Trial
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery
研究概览
简要总结
The primary objective is to assess efficacy of vitamin C compared to standard of care in reducing the systemic inflammatory reaction from before cardiac surgery until 72 hours after surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent prior to study participation
- •Adult patients (≥ 18 years)
- •Patients undergoing open-heart surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve or CABG or multiple valve surgeries, or combined cardiac/aortic surgical procedures and (ii) at least one of the following additional risk factors: a. a high perioperative risk profile, defined as a predicted operative mortality of ≥ 8% (EuroSCORE II) b. Age >70 years c. Clinical Frailty Scale >4 d. Urgent need for cardiac surgery (defined as to be performed within 24 to 48 hours after admission to hospital). e. Left ventricular ejection fraction <35%
- •The investigator considers the patient to be suitable for participating in the study
排除标准
- •Patients with history of recurrent formation of kidney stones (oxalate urolithiasis) or recent history (within 1 year) of any kidney stones
- •Patients who are enrolled in industry sponsored interventional trials. The enrolment of patients included in interventional investigator-initiated trials will be discussed on a case-by-case depending on potential confounders regarding this trial
- •Patients with severe renal insufficiency (CKD KDIGO Stage 4/5 or glomerular filtration rate < 30 ml/min)
- •Patients with known glucose-6-phosphate dehydrogenase deficiency.
- •Patients with known thalassemia, hemochromatosis and sideroblastic anemia.
- •Patients with known hypersensitivity to the Investigational Medicinal Product (IMP) or against any of its ingredients
- •Patients who are pregnant or lactating
- •Patients who are receiving high-dose IV vitamin C (enteral or oral vitamin C is allowed) already before surgery (>100 mg/kg/day as daily dose for > 1 week
- •Patients who are moribund (not expected to survive the next 72 hours from screening evaluation)
- •Patients with severe acid-base or electrolyte imbalances
结局指标
主要结局
The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery
The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery
次要结局
- 30 day and 6-month all-cause mortality
- Days alive and out of hospital
- Time to discharge alive (TDA)
- Persistent organ dysfunction and death
- ICU and hospital length of stay
- ICU and hospital readmission rates
- Area under the curve (AUC) of inflammatory markers (IL-1b, TNF-α and IFN-γ)
- Absolute values of daily measurements of C Reactive Protein (CRP), procalcitonin (PCT) and leukocytes during ICU stay
- Daily overall Sequential Organ Failure Assessment (SOFA) Score
- Duration and type (invasive or non-invasive) of mechanical ventilation
- Duration and dosage of sedative agents used postoperatively
- Occurrence of malignant arrhythmias
- Occurrence of atrial fibrillation
- Left ventricular ejection fraction (LVEF)
- New York Heart Association (NYHA) Classification
- Number of cerebral ischemic or hemorrhagic events
- Clinical Frailty Scale (CFS)
- Daily Confusion Assessment Method for the ICU (CAM-ICU) Score
- Urine output during the ICU length of stay
- Number of post operative complications including surgical re-evaluation, severe hemorrhage requiring surgical intervention, thromboembolic events requiring intervention, infection and sepsis
- Adverse Events leading to discontinuation/Adverse Events at least possibly related to the IMP/Serious Adverse Events and Adverse Events of Special Interest
- Entzündungsmarker, die mit Point-of-Care-Methoden am Krankenbett analysiert werden (z. B. IL-1, IL-6, IL-8, IL-10, TNF-α, IFN-γ, CRP, PCT, D-Dimer, Ferritin)
研究者
sponsor representative
Scientific
GCP-Service International West GmbH
研究点 (3)
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