Liver Transplantation Clinical Trial
— VITACTOHOfficial title:
Intravenous Vitamin C for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation From Deceased Donors
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | July 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 67 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario RAmon y Cajal | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Ramon y Cajal |
Spain,
Aggarwal S, Kang Y, Freeman JA, Fortunato FL, Pinsky MR. Postreperfusion syndrome: cardiovascular collapse following hepatic reperfusion during liver transplantation. Transplant Proc. 1987 Aug;19(4 Suppl 3):54-5. No abstract available. — View Citation
Bezinover D, Kadry Z, McCullough P, McQuillan PM, Uemura T, Welker K, Mastro AM, Janicki PK. Release of cytokines and hemodynamic instability during the reperfusion of a liver graft. Liver Transpl. 2011 Mar;17(3):324-30. doi: 10.1002/lt.22227. — View Citation
Blanot S, Gillon MC, Ecoffey C, Lopez I. Circulating endotoxins during orthotopic liver transplantation and post-reperfusion syndrome. Lancet. 1993 Oct 2;342(8875):859-60. doi: 10.1016/0140-6736(93)92715-6. No abstract available. — View Citation
Blanot S, Gillon MC, Lopez I, Ecoffey C. Circulating endotoxins and postreperfusion syndrome during orthotopic liver transplantation. Transplantation. 1995 Jul 15;60(1):103-6. doi: 10.1097/00007890-199507150-00019. No abstract available. — View Citation
Fowler AA 3rd, Syed AA, Knowlson S, Sculthorpe R, Farthing D, DeWilde C, Farthing CA, Larus TL, Martin E, Brophy DF, Gupta S; Medical Respiratory Intensive Care Unit Nursing; Fisher BJ, Natarajan R. Phase I safety trial of intravenous ascorbic acid in patients with severe sepsis. J Transl Med. 2014 Jan 31;12:32. doi: 10.1186/1479-5876-12-32. — View Citation
Girn HR, Ahilathirunayagam S, Mavor AI, Homer-Vanniasinkam S. Reperfusion syndrome: cellular mechanisms of microvascular dysfunction and potential therapeutic strategies. Vasc Endovascular Surg. 2007 Aug-Sep;41(4):277-93. doi: 10.1177/1538574407304510. — View Citation
Ishine N, Yagi T, Ishikawa T, Sasaki H, Nakagawa K, Tanaka N. Hemodynamic analysis of post-reperfusion syndrome and the effect of preventing this syndrome using thromboxane A2 synthetase inhibitor (OKY-046) in swine liver transplantation. Transplant Proc. 1997 Feb-Mar;29(1-2):378-81. doi: 10.1016/s0041-1345(96)00127-3. No abstract available. — View Citation
Paugam-Burtz C, Kavafyan J, Merckx P, Dahmani S, Sommacale D, Ramsay M, Belghiti J, Mantz J. Postreperfusion syndrome during liver transplantation for cirrhosis: outcome and predictors. Liver Transpl. 2009 May;15(5):522-9. doi: 10.1002/lt.21730. — View Citation
Siniscalchi A, Dante A, Spedicato S, Riganello L, Zanoni A, Cimatti M, Pierucci E, Bernardi E, Miklosova Z, Moretti C, Faenza S. Hyperdynamic circulation in acute liver failure: reperfusion syndrome and outcome following liver transplantation. Transplant Proc. 2010 May;42(4):1197-9. doi: 10.1016/j.transproceed.2010.03.097. — View Citation
Tanaka H, Matsuda T, Miyagantani Y, Yukioka T, Matsuda H, Shimazaki S. Reduction of resuscitation fluid volumes in severely burned patients using ascorbic acid administration: a randomized, prospective study. Arch Surg. 2000 Mar;135(3):326-31. doi: 10.1001/archsurg.135.3.326. — View Citation
Wilson JX. Mechanism of action of vitamin C in sepsis: ascorbate modulates redox signaling in endothelium. Biofactors. 2009 Jan-Feb;35(1):5-13. doi: 10.1002/biof.7. — View Citation
Zabet MH, Mohammadi M, Ramezani M, Khalili H. Effect of high-dose Ascorbic acid on vasopressor's requirement in septic shock. J Res Pharm Pract. 2016 Apr-Jun;5(2):94-100. doi: 10.4103/2279-042X.179569. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postreperfusion syndrome | 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 | Within the first 5 minutes after reperfusion of the grafted liver | |
Secondary | Ascorbic acid serum levels | Quantification of ascorbic acid levels before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | |
Secondary | Interleukin1beta (IL-1ß) levels | Quantification of IL-1ß before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | |
Secondary | Tumor Necrosis Factor-alpha (TNFa) levels | Quantification of TNFa before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | |
Secondary | Interleukin-6 levels (IL-6) | Quantification of IL-6 before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | |
Secondary | Interleukin-8 (IL-8) levels | Quantification of IL-8 before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | |
Secondary | Interferon gamma (IFN?) levels | Quantification of IFN? before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | |
Secondary | Primary graft dysfunction | 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 | First postoperative week | |
Secondary | Acute renal failure | Postoperative renal failure after liver transplantation as Kidney Disease Improving Global Outcomes (KDIGO) definition | First postoperative week | |
Secondary | Mechanical ventilation | Duration of mechanical ventilation (hours) until extubation of the patient | Postoperative until day 30 | |
Secondary | Mortality | Mortality of any cause | Up to day 30 | |
Secondary | Length of hospitalization | Length of stay in hospital (days) | Through study completion (30 days) | |
Secondary | Length of Intensive Care Unit (ICU) stay | Length of ICU stay | Through study completion (30 days) | |
Secondary | Duration of vasopressor support after transplantation | Duration of vasopressor or inotropic support after transplantation | Postoperative until study completion (30 days) | |
Secondary | Maximum dose of vasopressor support after transplantation | Maximum dose of vasopressor or inotropic support after transplantation | Postoperative until study completion (30 days) |
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