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OpenTrials
Active, Not Recruiting

NCT Number: NCT06395259

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transplantation Ascorbic Acid Deficiency Avitaminosis Cardiovascular Diseases Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Primary Graft Dysfunction Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, 20122, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Minor patients
  • Multi-organ transplantation

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. Mechanical ventilation

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

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

  5. Length of Intensive Care Unit (ICU) stay

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

    Length of ICU stay

  6. Allograft dysfunction

    Time frame: Within the first 7 days after transplantation

    Incidence of early allograft dysfunction (EAD in liver recipients), primary graft dysfunction (PGD in lung recipients), delayed graft function (DGF in kidney recipients)

  7. Mortality in Intensive Care Unit (ICU)

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

    Incidence of death for any cause during ICU stay

  8. Length of hospitalization

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

    Length of stay in hospital (days)

  9. Acute kidney injury (AKI)

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

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

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

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

Acronym: REDOX-TX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 2, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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