Ascorbic Acid to Prevent Postreperfusion Syndrome in Liver Transplantation
NCT ID: NCT05754242
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2020-11-17
2023-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation
NCT02423941
Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation
NCT01866644
Covid Vaccination in Liver Transplantation
NCT05079165
The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient
NCT03758352
Continuous Renal Replacement Therapy in the Setting of Orthotopic Liver Transplant
NCT01619449
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ascorbic acid
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
Ascorbic acid
1.5 gr of ascorbic acid
Saline solution
100 ml of 0.9% saline solution will be administered during the anhepatic phase of liver transplantation
0.9% Saline solution
100 ml of 0.9% saline solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ascorbic acid
1.5 gr of ascorbic acid
0.9% Saline solution
100 ml of 0.9% saline solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
67 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario Ramon y Cajal
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Luis Gajate Martín
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luis Gajate, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramón y Cajal
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario RAmon y Cajal
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EC 20/606
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.