Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation

Transplantation Clinical Trial

— REDOX-TX  

Official title:

Evaluation of the Oxidative Status of Patients Undergoing Solid Organs Transplantation: Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395259
• Other study ID #: 3334
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Policlinico Hospital
• Contact: Alberto Zanella
• Phone: +39 0255033275
• Email: alberto.zanella1[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this observational clinical study is to evaluate the variations in ascorbic acid during the transplantation phases and how these variations influence the oxidative status and patient outcome.

The main questions it aims to answer are:

• how many patients arrive at the transplant in a state of hypovitaminosis C?

• how does hypovitaminosis C affect the patient's oxidative status?

• how does hypovitaminosis C affect the length of stay in intensive care and post-transplant complications?

Description:

Researches will compared:

Differences between Hypovitaminosis Group and Normal Range Group Changes in oxidative stress markers before and after solid organ transplantation Incidence of allograft dysfunction between groups Incidence of acute kidney injury and other complications between groups

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing solid organ transplantation (liver or kidney or lung)

Exclusion Criteria:

• Minor patients

• Multi-organ transplantation

Related Conditions & MeSH terms

• Ascorbic Acid Deficiency
• Transplantation

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (13)

Borran M, Dashti-Khavidaki S, Alamdari A, Naderi N. Vitamin C and kidney transplantation: Nutritional status, potential efficacy, safety, and interactions. Clin Nutr ESPEN. 2021 Feb;41:1-9. doi: 10.1016/j.clnesp.2020.12.017. Epub 2021 Jan 9. — View Citation

Fernandez AR, Sanchez-Tarjuelo R, Cravedi P, Ochando J, Lopez-Hoyos M. Review: Ischemia Reperfusion Injury-A Translational Perspective in Organ Transplantation. Int J Mol Sci. 2020 Nov 13;21(22):8549. doi: 10.3390/ijms21228549. — View Citation

Frei B, Stocker R, England L, Ames BN. Ascorbate: the most effective antioxidant in human blood plasma. Adv Exp Med Biol. 1990;264:155-63. doi: 10.1007/978-1-4684-5730-8_24. — View Citation

Gori F, Fumagalli J, Lonati C, Caccialanza R, Zanella A, Grasselli G. Ascorbic acid in solid organ transplantation: A literature review. Clin Nutr. 2022 Jun;41(6):1244-1255. doi: 10.1016/j.clnu.2022.04.004. Epub 2022 Apr 12. — View Citation

Hill A, Borgs C, Fitzner C, Stoppe C. Perioperative Vitamin C and E levels in Cardiac Surgery Patients and Their Clinical Significance. Nutrients. 2019 Sep 9;11(9):2157. doi: 10.3390/nu11092157. — View Citation

Kumar S, Sharma U, Sharma A, Kenwar DB, Singh S, Prasad R, Minz M. Evaluation of oxidant and antioxidant status in living donor renal allograft transplant recipients. Mol Cell Biochem. 2016 Feb;413(1-2):1-8. doi: 10.1007/s11010-015-2617-6. Epub 2016 Jan 13. — View Citation

Oudemans-van Straaten HM, Spoelstra-de Man AM, de Waard MC. Vitamin C revisited. Crit Care. 2014 Aug 6;18(4):460. doi: 10.1186/s13054-014-0460-x. — View Citation

Pak O, Sydykov A, Kosanovic D, Schermuly RT, Dietrich A, Schroder K, Brandes RP, Gudermann T, Sommer N, Weissmann N. Lung Ischaemia-Reperfusion Injury: The Role of Reactive Oxygen Species. Adv Exp Med Biol. 2017;967:195-225. doi: 10.1007/978-3-319-63245-2_12. — View Citation

Shi S, Xue F. Current Antioxidant Treatments in Organ Transplantation. Oxid Med Cell Longev. 2016;2016:8678510. doi: 10.1155/2016/8678510. Epub 2016 Jun 15. — View Citation

Sotomayor CG, Eisenga MF, Gomes Neto AW, Ozyilmaz A, Gans ROB, Jong WHA, Zelle DM, Berger SP, Gaillard CAJM, Navis GJ, Bakker SJ. Vitamin C Depletion and All-Cause Mortality in Renal Transplant Recipients. Nutrients. 2017 Jun 2;9(6):568. doi: 10.3390/nu9060568. — View Citation

Spoelstra-de Man AME, Elbers PWG, Oudemans-van Straaten HM. Making sense of early high-dose intravenous vitamin C in ischemia/reperfusion injury. Crit Care. 2018 Mar 20;22(1):70. doi: 10.1186/s13054-018-1996-y. — View Citation

Wang Y, Lin H, Lin BW, Lin JD. Effects of different ascorbic acid doses on the mortality of critically ill patients: a meta-analysis. Ann Intensive Care. 2019 May 20;9(1):58. doi: 10.1186/s13613-019-0532-9. — View Citation

Williams A, Riise GC, Anderson BA, Kjellstrom C, Schersten H, Kelly FJ. Compromised antioxidant status and persistent oxidative stress in lung transplant recipients. Free Radic Res. 1999 May;30(5):383-93. doi: 10.1080/10715769900300421. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascorbic Acid levels	Quantification of plasma ascorbic acid levels before and after liver/kidney/lung transplantation	At induction of anesthesia for TX, within 24h from ICU admission, 72 hours after transplantation, 7 days after transplantation
Secondary	Reactive Oxygen Species (ROS) levels	Quantification of ROS before and after liver/kidney/lung transplantation	At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
Secondary	Total Antioxidant Capacity (TAC) levels	Quantification of TAC before and after liver/kidney/lung transplantation	At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
Secondary	8-hydroxydeoxyguanosine (8-OHdG) levels	Quantification of 8-OHdG before and after liver/kidney/lung transplantation	At induction of anesthesia TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
Secondary	Mechanical ventilation	Duration of mechanical ventilation (days) until extubation of the recipient	From ICU admission until extubation occurs, assessed daily up to 100 days from transplantation
Secondary	Length of Intensive Care Unit (ICU) stay	Length of ICU stay	From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
Secondary	Allograft dysfunction	Incidence of early allograft dysfunction (EAD in liver recipients), primary graft dysfunction (PGD in lung recipients), delayed graft function (DGF in kidney recipients)	Within the first 7 days after transplantation
Secondary	Mortality in Intensive Care Unit (ICU)	Incidence of death for any cause during ICU stay	From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
Secondary	Length of hospitalization	Length of stay in hospital (days)	From ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantation
Secondary	Acute kidney injury (AKI)	Incidence of postoperative renal injury after liver/kidney/lung transplantation as Kidney Disease Improving Global Outcomes (KDIGO) criteria	Worst kidney function within the first 7 days after TX