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

NCT06395259 | Active Not Recruiting

• 1 other identifier: 3334
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Transplantation; Ascorbic Acid Deficiency

Keywords

Transplantation; Ascorbic Acid; Oxidative Stress; Primary Graft Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Reactive Oxygen Species (ROS) levels

  At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation

• Total Antioxidant Capacity (TAC) levels

  At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation

• 8-hydroxydeoxyguanosine (8-OHdG) levels

  At induction of anesthesia TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation

• Mechanical ventilation

  From ICU admission until extubation occurs, assessed daily up to 100 days from transplantation

• Length of Intensive Care Unit (ICU) stay

  From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation

Study Arms (2)

Hypovitaminosis Group

Patients who at the end of surgery have sub-optimal plasma ascorbic acid levels, i.e. with concentrations lower than 28 µmol/L

Normal Range Group

Patients who at the end of surgery have plasma ascorbic acid levels equal to or greater than 28 µmol/L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing liver, lungs or kidneys transplantation at Ospedale Maggiore in Milan. There is no control group

You may qualify if:

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

You may not qualify if:

• Minor patients
• Multi-organ transplantation

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

Location

Related Publications (13)

• 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.

  PMID: 33202744 BACKGROUND

• 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.

  PMID: 29047088 BACKGROUND

• 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.

  PMID: 27403232 BACKGROUND

• 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.

  PMID: 10342331 BACKGROUND

• 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.

  PMID: 26762627 BACKGROUND

• 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.

  PMID: 28574431 BACKGROUND

• 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.

  PMID: 31505814 BACKGROUND

• 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.

  PMID: 33487249 BACKGROUND

• 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.

  PMID: 2244489 BACKGROUND

• 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.

  PMID: 25185110 BACKGROUND

• 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.

  PMID: 29558975 BACKGROUND

• 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.

  PMID: 31111241 BACKGROUND

• 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.

  PMID: 35504167 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples are collected (in lithium-heparin tubes), appropriately centrifuged, and the plasma thus obtained is frozen at -80°

MeSH Terms

Conditions

Ascorbic Acid Deficiency; Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: May 2, 2024
• Study Start: February 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

IT (1)