Liver Transplantation, Postreperfusion Syndrome, Ascorbic Acid
Conditions
Keywords
Postreperfusion syndrome
Brief summary
The goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are: * Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ? * Can ascorbic acid decrease the incidence of liver graft dysfunction after liver transplantation? * Can ascorbic acid decreased the incidence of postoperative complications after liver transplantation ? Participants will receive 1.5 g of intravenous ascorbic acid diluted in 100 ml of saline or 100 ml of saline alone, during the anhepatic phase of liver transplantation before reperfusion of the new graft. Researchers will compared the incidence of postreperfusion syndrome in both groups.
Detailed description
Researches will compared: * Incidence of postreperfusion syndrome in liver transplantation * Changes in interleukin values and other inflammatory markers before and after transplantation * Incidence of liver graft dysfunction between groups * Incidence of acute renal failure and other complications between groups
Interventions
DRUGAscorbic acid
1.5 gr of ascorbic acid
100 ml of 0.9% saline solution
Sponsors
Hospital Universitario Ramon y Cajal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing liver transplantation
Exclusion criteria
* Pregnancy * Allergy to ascorbic acid * Nephrolithiasis * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Hyperoxaluria * Hyperuricemia * Haemochromatosis * Sickle cell anemia * Serum Creatinine \> 1.2 mg/dl in women and 1.3 mg/dl in men * Split liver graft * Acute liver failure * Living donor liver transplantation * Controlled donor asystolia * Treatment with: indinavir, Vitamin B12, Cyclosporine, iron, deferoxamine, disulfiram
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postreperfusion syndrome | Within the first 5 minutes after reperfusion of the grafted liver | When mean arterial pressure decreases by more than 30% relative to the value at the end of the anhepatic phase and lasts for at least 1 min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ascorbic acid serum levels | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | Quantification of ascorbic acid levels before and after liver transplantation |
| Interleukin1beta (IL-1β) levels | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | Quantification of IL-1β before and after liver transplantation |
| Tumor Necrosis Factor-alpha (TNFα) levels | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | Quantification of TNFα before and after liver transplantation |
| Interleukin-6 levels (IL-6) | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | Quantification of IL-6 before and after liver transplantation |
| Interleukin-8 (IL-8) levels | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | Quantification of IL-8 before and after liver transplantation |
| Interferon gamma (IFNγ) levels | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | Quantification of IFNγ before and after liver transplantation |
| Primary graft dysfunction | First postoperative week | Incidence of primary graft nonfunction and early graft dysfunction. Graft nonfunction: lack of liver function leading to death if not retransplanted Early graft dysfunction: Olthoff's criteria |
| Acute renal failure | First postoperative week | Postoperative renal failure after liver transplantation as Kidney Disease Improving Global Outcomes (KDIGO) definition |
| Mechanical ventilation | Postoperative until day 30 | Duration of mechanical ventilation (hours) until extubation of the patient |
| Mortality | Up to day 30 | Mortality of any cause |
| Length of hospitalization | Through study completion (30 days) | Length of stay in hospital (days) |
| Length of Intensive Care Unit (ICU) stay | Through study completion (30 days) | Length of ICU stay |
| Duration of vasopressor support after transplantation | Postoperative until study completion (30 days) | Duration of vasopressor or inotropic support after transplantation |
| Maximum dose of vasopressor support after transplantation | Postoperative until study completion (30 days) | Maximum dose of vasopressor or inotropic support after transplantation |
Countries
Spain
Contacts
Primary ContactLuis Gajate, MD PhD
Backup ContactInes de la Hoz, MD
Outcome results
None listed