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Active, not recruitingNCT06395259REDOX-TXUpdated Sep 4, 2024

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

An observational study in Transplantation and Ascorbic Acid Deficiency, sponsored by Policlinico Hospital. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.

Sponsored by Policlinico Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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?
Read the detailed 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

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Conditions studied

  • Transplantation
  • Ascorbic Acid Deficiency

Keywords

  • Transplantation
  • Ascorbic Acid
  • Oxidative Stress
  • Primary Graft Dysfunction
03

In context

Primary Graft Dysfunction

26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 13 observational studies indexed under Primary Graft Dysfunction.

Browse Primary Graft Dysfunction studies →

Lead sponsor

Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Minor patients
  • Multi-organ transplantation
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Ascorbic Acid levels

    Quantification of plasma ascorbic acid levels before and after liver/kidney/lung transplantation

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

Secondary outcomes

  1. Reactive Oxygen Species (ROS) levels

    Quantification of ROS before and after liver/kidney/lung transplantation

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

  2. Total Antioxidant Capacity (TAC) levels

    Quantification of TAC before and after liver/kidney/lung transplantation

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

  3. 8-hydroxydeoxyguanosine (8-OHdG) levels

    Quantification of 8-OHdG before and after liver/kidney/lung transplantation

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

  4. Mechanical ventilation

    Duration of mechanical ventilation (days) until extubation of the recipient

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

  5. Length of Intensive Care Unit (ICU) stay

    Length of ICU stay

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

  6. 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)

    Time frame: Within the first 7 days after transplantation

  7. Mortality in Intensive Care Unit (ICU)

    Incidence of death for any cause during ICU stay

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

  8. Length of hospitalization

    Length of stay in hospital (days)

    Time frame: From ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantation

  9. Acute kidney injury (AKI)

    Incidence of postoperative renal injury after liver/kidney/lung transplantation as Kidney Disease Improving Global Outcomes (KDIGO) criteria

    Time frame: Worst kidney function within the first 7 days after TX

07

Study locations

1 site
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References and documents

Publications

  • 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. PubMed 33202744 ↗
  • 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. PubMed 29047088 ↗
  • 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. PubMed 27403232 ↗
  • 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. PubMed 10342331 ↗
  • 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. PubMed 26762627 ↗
  • 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. PubMed 28574431 ↗
  • 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. PubMed 31505814 ↗
  • 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. PubMed 33487249 ↗
  • 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. PubMed 2244489 ↗
  • 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. PubMed 25185110 ↗
  • 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. PubMed 29558975 ↗
  • 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. PubMed 31111241 ↗
  • 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. PubMed 35504167 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06395259
Lead sponsor
Policlinico Hospital
Responsible party
Giacomo Grasselli (MD, University of Milan) — Principal investigator
First posted
May 2, 2024
Start date
Feb 1, 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024 (estimated)
Last update
Sep 4, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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