TransplantationREDOX-TXNCT06395259
Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation
An observational study of Transplantation and Ascorbic Acid Deficiency, run by Policlinico Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Ascorbic Acid Deficiency
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver, lungs or kidneys transplantation at Ospedale Maggiore in Milan. There is no control group
Who may be able to join
- Adult patients undergoing solid organ transplantation (liver or kidney or lung)
Who cannot join
- Minor patients
- Multi-organ transplantation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
About this study
Official title: Evaluation of the Oxidative Status of Patients Undergoing Solid Organs Transplantation: Observational Study
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
- Conditions
- Transplantation, Ascorbic Acid Deficiency
- Keywords
- Transplantation, Ascorbic Acid, Oxidative Stress, Primary Graft Dysfunction
- Medical subject headings
- Ascorbic Acid Deficiency, Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascorbic Acid levels
Quantification of plasma ascorbic acid levels before and after liver/kidney/lung transplantation
Measured: 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
Quantification of ROS before and after liver/kidney/lung transplantation
Measured: 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
Quantification of TAC before and after liver/kidney/lung transplantation
Measured: 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
Quantification of 8-OHdG before and after liver/kidney/lung transplantation
Measured: At induction of anesthesia TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
Mechanical ventilation
Duration of mechanical ventilation (days) until extubation of the recipient
Measured: From ICU admission until extubation occurs, assessed daily up to 100 days from transplantation
Length of Intensive Care Unit (ICU) stay
Length of ICU stay
Measured: From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
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)
Measured: Within the first 7 days after transplantation
Mortality in Intensive Care Unit (ICU)
Incidence of death for any cause during ICU stay
Measured: From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
Length of hospitalization
Length of stay in hospital (days)
Measured: From ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantation
Acute kidney injury (AKI)
Incidence of postoperative renal injury after liver/kidney/lung transplantation as Kidney Disease Improving Global Outcomes (KDIGO) criteria
Measured: Worst kidney function within the first 7 days after TX
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Feb 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395259
- Sponsor's protocol ID
- 3334
- Acronym
- REDOX-TX
- Status last verified
- Sep 2024
- First submitted
- 24 Jan 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33202744Pak 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 29047088Shi 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 27403232Williams 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 10342331Kumar 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 26762627Sotomayor 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 28574431Hill 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 31505814Borran 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 33487249Frei 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 2244489Oudemans-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 25185110Spoelstra-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 29558975Wang 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 31111241Gori 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Oxidative Status of Patients Undergoing Solid Organs Transplantation: Observational Study
- ClinicalTrials.gov ID
- NCT06395259
- Acronym / sponsor ID
- REDOX-TX / 3334
- Conditions
- Transplantation, Ascorbic Acid Deficiency
- Keywords
- Transplantation, Ascorbic Acid, Oxidative Stress, Primary Graft Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver, lungs or kidneys transplantation at Ospedale Maggiore in Milan. There is no control group
Key inclusion criteria (1 listed)
- Adult patients undergoing solid organ transplantation (liver or kidney or lung)
Key exclusion criteria (2 listed)
- Minor patients
- Multi-organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ascorbic Acid levels
Time frame: At induction of anesthesia for TX, within 24h from ICU admission, 72 hours after transplantation, 7 days after transplantation
Quantification of plasma ascorbic acid levels before and after liver/kidney/lung transplantation
9 secondary outcomes
Reactive Oxygen Species (ROS) levels
Time frame: 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
Time frame: 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
Time frame: At induction of anesthesia TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
Mechanical ventilation
Time frame: From ICU admission until extubation occurs, assessed daily up to 100 days from transplantation
Length of Intensive Care Unit (ICU) stay
Time frame: From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
Allograft dysfunction
Time frame: Within the first 7 days after transplantation
Mortality in Intensive Care Unit (ICU)
Time frame: From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
Length of hospitalization
Time frame: From ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantation
Acute kidney injury (AKI)
Time frame: Worst kidney function within the first 7 days after TX
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 33202744Fernandez 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.
- Background: PubMed 29047088Pak 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.
- Background: PubMed 27403232Shi 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.
- Background: PubMed 10342331Williams 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.
- Background: PubMed 26762627Kumar 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.
- Background: PubMed 28574431Sotomayor 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.
- Background: PubMed 31505814Hill 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.
- Background: PubMed 33487249Borran 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.
- Background: PubMed 2244489Frei 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.
- Background: PubMed 25185110Oudemans-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.
- Background: PubMed 29558975Spoelstra-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.
- Background: PubMed 31111241Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplantation and Ascorbic Acid Deficiency, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ascorbic Acid levels (time frame: At induction of anesthesia for TX, within 24h from ICU admission, 72 hours after transplantation, 7 days after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395259, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.