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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06395259
Acronym
REDOX-TX
Enrollment
40
Registered
2024-05-02
Start date
2023-02-01
Completion date
2024-08-31
Last updated
2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascorbic Acid Deficiency, Transplantation

Keywords

Transplantation, Ascorbic Acid, Oxidative Stress, Primary Graft Dysfunction

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?

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

Interventions

None listed

Sponsors

Policlinico Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Minor patients * Multi-organ transplantation

Design outcomes

Primary

MeasureTime frameDescription
Ascorbic Acid levelsAt induction of anesthesia for TX, within 24h from ICU admission, 72 hours after transplantation, 7 days after transplantationQuantification of plasma ascorbic acid levels before and after liver/kidney/lung transplantation

Secondary

MeasureTime frameDescription
Total Antioxidant Capacity (TAC) levelsAt induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantationQuantification of TAC before and after liver/kidney/lung transplantation
8-hydroxydeoxyguanosine (8-OHdG) levelsAt induction of anesthesia TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantationQuantification of 8-OHdG before and after liver/kidney/lung transplantation
Mechanical ventilationFrom ICU admission until extubation occurs, assessed daily up to 100 days from transplantationDuration of mechanical ventilation (days) until extubation of the recipient
Length of Intensive Care Unit (ICU) stayFrom ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantationLength of ICU stay
Reactive Oxygen Species (ROS) levelsAt induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantationQuantification of ROS before and after liver/kidney/lung transplantation
Mortality in Intensive Care Unit (ICU)From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantationIncidence of death for any cause during ICU stay
Length of hospitalizationFrom ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantationLength of stay in hospital (days)
Acute kidney injury (AKI)Worst kidney function within the first 7 days after TXIncidence of postoperative renal injury after liver/kidney/lung transplantation as Kidney Disease Improving Global Outcomes (KDIGO) criteria
Allograft dysfunctionWithin the first 7 days after transplantationIncidence of early allograft dysfunction (EAD in liver recipients), primary graft dysfunction (PGD in lung recipients), delayed graft function (DGF in kidney recipients)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026