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Antioxidant Treatment with Vitamin C in Cardiac Surgery Patients – A Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510561-10-00
Acronym
The ACCURATE Study
Enrollment
60
Registered
2024-05-28
Start date
2024-07-19
Completion date
Unknown
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular illness, Intensive care unit (ICU), open-heart surgery

Brief summary

The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery

Detailed description

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)

Interventions

DRUGPascorbin® Wirkstoff: Ascorbinsäure 150 mg pro ml Injektionslösung

Sponsors

GCP-Service International West GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The area under the curve of serum levels of IL-6 from baseline to 72 hours after surgery

Secondary

MeasureTime frame
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 inc

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026