Pilot study about the use of intravenous Vitamin C for the prevention of Reperfusion Syndrome in Orthotopic Liver Transplantation from a cadaver donor.

Phase II clinical trial, randomized, double blind, masked, controlled with physiological serum about the efficacy of intravenous administration of vitamin C during the anhepatic phase of liver transplantation to prevent the onset of reperfusion syndrome - VITACTOH

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000123-39-ES

Enrollment

Registered

2020-02-28

Start date

2020-04-02

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

Reperfusion syndrome

Interventions

Trade Name: Ácido Ascórbico Bayer 1.000 mg/5 ml solución inyectable Pharmaceutical Form: Solution for injection INN or Proposed INN: Ascorbic acid (D.C.I.) CAS Number: 50-81-7 Current Sponsor code: BA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients, who after receiving the information about the design, the purposes of the study, the possible risks that may arise from it and that at any time they may deny their collaboration, give their informed consent in writing to take part in the study. • Be between 18 and 67 years of age • Understand the purpose of the study • Patients who are going to undergo HT from a cadaver donor and who have been included in the waiting list after the relevant evaluation of the patient selection committee. • Pregnancy test in urine performed in the 7 days prior to the start of treatment under study in premenopausal women is negative or =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • Pregnancy or planning to become pregnant during the course of the study. Lactation. • Known or suspected hypersensitivity to intravenous vitamin C or any of its excipients (methyl parahydroxybenzoate - E-218 -, propyl parahydroxybenzoate - E-216 -). • Nephrolithiasis or history of nephrolithiasis. • Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis). • Hyperoxaluria. • Hyperuricemia / gout (risk of uric acid deposits). • Hemochromatosis. • Sickle cell disease. • Being treated with deferoxamine, indinavir, cyanocobalamin (Vitamin B12), cyclosporine, disulfirate or iron. • Preoperative renal failure defined as serum creatinine greater than 1.2 mg / dl in women and 1.3 mg / dl in men. • Split type liver transplant. • Fulminant hepatitis as an indication of transplant. • Graft from living-related donor or donor in asystole

Design outcomes

Primary

Measure	Time frame
Main Objective: Incidence of the appearance of reperfusion syndrome in orthotopic liver transplantation from cadaver donor.;Secondary Objective: - Analyze Vitamin C levels before and after TH. - Analyze the levels of inflammatory markers before and after (12 hours after reperfusion) of TH (IL-1ß, TNFa, IL-6, IL-8 and IFN?). Compare the values between the treated group and the control group - Incidence of early dysfunction and primary graft failure - Length of stay in the ICU and hospital - Duration of Mechanical ventilation. - Doses and duration of administration of vasopressor and inotropic drugs from the moment of graft reperfusion - Incidence of postoperative renal failure - Graft and patient survival 30 days after transplant;Primary end point(s): Percentage of patients who develop reperfusion syndrome (SR) during the intervention.;Timepoint(s) of evaluation of this end point: During the surgery	—

Measure

Time frame

Main Objective: Incidence of the appearance of reperfusion syndrome in orthotopic liver transplantation from cadaver donor.;Secondary Objective: - Analyze Vitamin C levels before and after TH. - Analyze the levels of inflammatory markers before and after (12 hours after reperfusion) of TH (IL-1ß, TNFa, IL-6, IL-8 and IFN?). Compare the values between the treated group and the control group - Incidence of early dysfunction and primary graft failure - Length of stay in the ICU and hospital - Duration of Mechanical ventilation. - Doses and duration of administration of vasopressor and inotropic drugs from the moment of graft reperfusion - Incidence of postoperative renal failure - Graft and patient survival 30 days after transplant;Primary end point(s): Percentage of patients who develop reperfusion syndrome (SR) during the intervention.;Timepoint(s) of evaluation of this end point: During the surgery

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Secondary

Measure	Time frame
Secondary end point(s): 1. Percentage of subjects with primary failure and early graft dysfunction to. a. Primary graft failure: Total failure of the liver graft function that requires the inclusion of the patient on the waiting list in a situation of Alert 0 for the realization of retransplantation, without which the patient's survival is not possible. b. Early graft dysfunction: Situation of graft dysfunction, which does not require its retransplantation. Patient survival is likely and possible without retransplantation, although morbidity will be greater than in the case of normofunctional grafts. Olthoff's criteria will be used for its definition (one criterion is sufficient) • Bilirubin greater than or equal to 10 mg / dL on day 7 postoperatively. • INR greater than or equal to 1.6 on day 7 of the postoperative period. • ALT or AST greater than 2000 IU / ml in the first 7 days of the postoperative period. 2. Time spent in the ICU and hospital. Days of stay in the Surgical Intensive Care Unit (UCQ) and total days of hospital stay in the first admission since the transplant. 3. Dose and duration of catecholamines from the time of reperfusion. Catecholamines used from the time of reperfusion of the graft, dose and duration of the graft (in micrograms / Kg / min and hours of duration) 4. Duration of mechanical ventilation. Time to extubation of the patient since admission to the UCQ in hours. 5. Vitamin C levels before and 12 hours after TH. The measurements will be made using high pressure liquid chromatography (HPLC) technique with ultraviolet detector in the Central Support Unit for Molecular Quantification and Characterization (UCA-CCM) of IRYCIS (Ramón y Cajal Hospital). 6. Levels of pre and post-transplant inflammatory markers (IL-1ß, TNFa, IL-6, IL-8 and IFN?) using ELISA HS technique to be performed in the Immunology Service of Ramón y Cajal Hospital. 7. Development of postoperative renal failure (AKI) in the first week. AKI is defined as an increase great	—

Measure

Time frame

Secondary end point(s): 1. Percentage of subjects with primary failure and early graft dysfunction to. a. Primary graft failure: Total failure of the liver graft function that requires the inclusion of the patient on the waiting list in a situation of Alert 0 for the realization of retransplantation, without which the patient's survival is not possible. b. Early graft dysfunction: Situation of graft dysfunction, which does not require its retransplantation. Patient survival is likely and possible without retransplantation, although morbidity will be greater than in the case of normofunctional grafts. Olthoff's criteria will be used for its definition (one criterion is sufficient) • Bilirubin greater than or equal to 10 mg / dL on day 7 postoperatively. • INR greater than or equal to 1.6 on day 7 of the postoperative period. • ALT or AST greater than 2000 IU / ml in the first 7 days of the postoperative period. 2. Time spent in the ICU and hospital. Days of stay in the Surgical Intensive Care Unit (UCQ) and total days of hospital stay in the first admission since the transplant. 3. Dose and duration of catecholamines from the time of reperfusion. Catecholamines used from the time of reperfusion of the graft, dose and duration of the graft (in micrograms / Kg / min and hours of duration) 4. Duration of mechanical ventilation. Time to extubation of the patient since admission to the UCQ in hours. 5. Vitamin C levels before and 12 hours after TH. The measurements will be made using high pressure liquid chromatography (HPLC) technique with ultraviolet detector in the Central Support Unit for Molecular Quantification and Characterization (UCA-CCM) of IRYCIS (Ramón y Cajal Hospital). 6. Levels of pre and post-transplant inflammatory markers (IL-1ß, TNFa, IL-6, IL-8 and IFN?) using ELISA HS technique to be performed in the Immunology Service of Ramón y Cajal Hospital. 7. Development of postoperative renal failure (AKI) in the first week. AKI is defined as an increase great

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Countries

Spain

Contacts

Public ContactAnabel Sánchez

Fundación Investigación Biomédica Hospital Ramón y Cajal

anabelsanchez.hrc@gmail.com+3491338825

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026