Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT04494451
Eligibility Criteria:
Inclusion Criteria:
\- Critically ill cirrhotics with MDR infections
Exclusion Criteria:
* Patients with age less than 18 years
* Known severe cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
* Patients in DIC with platelets \< 20,000 and INR \> 4 or active bleeding
* Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including "do not intubate" (DNI) status
* Current hospitalization \> 15 days for patients with nosocomial acquisition of MDR at time of randomization
* Known allergy or contraindication to vitamin C (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion,
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
* Use of vitamin C at a dose of \> 1 gram daily within the 24 hours preceding first episode of qualifying organ dysfunction during a given ED or ICU admission
* Patients with HCC (beyond Milan) or extrahepatic malignancies
* Patients with HVOTO or EHPVO
* Pregnancy or active breastfeeding
* Current participation in another interventional research study
* Active or history of kidney stone
* History of chronic kidney disease or intrinsic kidney disease
* Patients already on maintenance hemodialysis prior to presentation
* Patients with refractory septic shock or hypoxemia (Pa02/Fio2 ratio \<100)
* Extremely moribund patients with an expected life expectancy of less than 24 hours
* Failure to provide informed consent
* Patients with retroviral infection
* Patients with acute on chronic liver failure (APASL definition)
* Patients with urinary tract infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04494451
Study Brief:
Protocol Section:
NCT04494451