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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:
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.
Researches will compared:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascorbic acid | Experimental | 1.5 gr of ascorbic acid diluted in 100 ml of 0.9% saline solution will be administered intravenously during the anhepatic phase of liver transplantation |
|
| Saline solution | Placebo Comparator | 100 ml of 0.9% saline solution will be administered during the anhepatic phase of liver transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic acid | Drug | 1.5 gr of ascorbic acid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Interleukin1beta (IL-1β) levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Gajate, MD PhD | Contact | +34913368269 | gajate.luis@gmail.com | |
| Ines de la Hoz, MD | Contact | +34913368269 | delahozpoloines@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis Gajate, MD PhD | Hospital Universitario Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario RAmon y Cajal | Recruiting | Madrid | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3303534 | Background | 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. | |
| 20534260 | Background | 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. |
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All individual participant data (IPD) that underlie results in a publication
6 months after publication
Access by mail to principal investigator: gajate.luis@gmail.com
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 0.9% Saline solution | Drug | 100 ml of 0.9% saline solution |
|
|
Quantification of IL-1β before and after liver transplantation
| Immediately before induction of anesthesia and 12 hours after repercussion of the graft |
| Tumor Necrosis Factor-alpha (TNFα) levels | Quantification of TNFα before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft |
| 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 |
| 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 |
| Interferon gamma (IFNγ) levels | Quantification of IFNγ before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft |
| 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 |
| Acute renal failure | Postoperative renal failure after liver transplantation as Kidney Disease Improving Global Outcomes (KDIGO) definition | First postoperative week |
| Mechanical ventilation | Duration of mechanical ventilation (hours) until extubation of the patient | Postoperative until day 30 |
| Mortality | Mortality of any cause | Up to day 30 |
| Length of hospitalization | Length of stay in hospital (days) | Through study completion (30 days) |
| Length of Intensive Care Unit (ICU) stay | Length of ICU stay | Through study completion (30 days) |
| Duration of vasopressor support after transplantation | Duration of vasopressor or inotropic support after transplantation | Postoperative until study completion (30 days) |
| Maximum dose of vasopressor support after transplantation | Maximum dose of vasopressor or inotropic support after transplantation | Postoperative until study completion (30 days) |
| 19399736 | Background | 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. |
| 7624932 | Background | 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. |
| 21384515 | Background | 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. |
| 8104281 | Background | 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. |
| 9123045 | Background | 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. |
| 17704330 | Background | 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. |
| 19319840 | Background | 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. |
| 10722036 | Background | 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. |
| 27162802 | Background | 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. |
| 24484547 | Background | 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. |
| 38100226 | Derived | Gajate L, de la Hoz I, Espino M, Martin Gonzalez MDC, Fernandez Martin C, Martin-Grande A, Parise Roux D, Pastor O, Villahoz J, Rodriguez-Gandia MA, Nuno Vazquez J. Intravenous Ascorbic Acid for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 15;12:e50091. doi: 10.2196/50091. |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |