ASCORBIC ACID for Cardiac surgery (open-heart surgery) | Cardiovascular disease

Inclusion criteria

• {"criterion_text":"- Written informed consent prior to study participation\n- Adult patients (≥ 18 years)\n- 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%\n- The investigator considers the patient to be suitable for participating in the study"}

Exclusion criteria

• {"criterion_text":"- Patients with history of recurrent formation of kidney stones (oxalate urolithiasis) or recent history (within 1 year) of any kidney stones\n- 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\n- Patients with severe renal insufficiency (CKD KDIGO Stage 4/5 or glomerular filtration rate < 30 ml/min)\n- Patients with known glucose-6-phosphate dehydrogenase deficiency.\n- Patients with known thalassemia, hemochromatosis and sideroblastic anemia.\n- Patients with known hypersensitivity to the Investigational Medicinal Product (IMP) or against any of its ingredients\n- Patients who are pregnant or lactating\n- 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\n- Patients who are moribund (not expected to survive the next 72 hours from screening evaluation)\n- Patients with severe acid-base or electrolyte imbalances"}

Primary endpoints

• {"endpoint_text":"- The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery","definition_or_measurement_approach":"Area under the curve (AUC) of serum IL-6 measured from baseline to 72 hours post-surgery"}

Secondary endpoints

• {"endpoint_text":"- 30 day and 6-month all-cause mortality\n- Days alive and out of hospital\n- Time to discharge alive (TDA)\n- Persistent organ dysfunction and death\n- ICU and hospital length of stay\n- ICU and hospital readmission rates\n- Area under the curve (AUC) of inflammatory markers (IL-1b, TNF-α and IFN-γ)\n- Absolute values of daily measurements of C Reactive Protein (CRP), procalcitonin (PCT) and leukocytes during ICU stay\n- Daily overall Sequential Organ Failure Assessment (SOFA) Score\n- Duration and type (invasive or non-invasive) of mechanical ventilation\n- Duration and dosage of sedative agents used postoperatively\n- Occurrence of malignant arrhythmias\n- Occurrence of atrial fibrillation\n- Left ventricular ejection fraction (LVEF)\n- New York Heart Association (NYHA) Classification\n- Number of cerebral ischemic or hemorrhagic events\n- Clinical Frailty Scale (CFS)\n- Daily Confusion Assessment Method for the ICU (CAM-ICU) Score\n- Urine output during the ICU length of stay\n- Number of post operative complications including surgical re-evaluation, severe hemorrhage requiring surgical intervention, thromboembolic events requiring intervention, infection and sepsis\n- Adverse Events leading to discontinuation/Adverse Events at least possibly related to the IMP/Serious Adverse Events and Adverse Events of Special Interest\n- 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)","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

16-05-2024

Latest Decision Or Authorization Date

28-05-2025

Processing Time Days

377

Number Of Sites

3

Number Of Participants

60

Primary sponsor

Full Name

GCP-Service International West GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"GCP-Service International Limited & Co. KG","duties_or_roles":"Codes: 1,10,11,12,14,2,3,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Deutsche Institut für Ernährungsforschung","duties_or_roles":"Code: 4","organisation_type":"Health care"}
• {"country":"Germany","full_name":"Bremen Briteline GmbH","duties_or_roles":"Code: 15 (Server Hosting)","organisation_type":"Non-Pharmaceutical company"}