Clinical trial NCT06395259: Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation
Official title: Evaluation of the Oxidative Status of Patients Undergoing Solid Organs Transplantation: Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transplantation
Ascorbic Acid Deficiency
Keywords: Transplantation
Ascorbic Acid
Oxidative Stress
Primary Graft Dysfunction
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing liver, lungs or kidneys transplantation at Ospedale Maggiore in Milan. There is no control group

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Minor patients
* Multi-organ transplantation

Primary outcomes:
measure: Ascorbic Acid levels
timeFrame: At induction of anesthesia for TX, within 24h from ICU admission, 72 hours after transplantation, 7 days after transplantation
Secondary outcomes:
measure: Reactive Oxygen Species (ROS) levels
timeFrame: At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
measure: Total Antioxidant Capacity (TAC) levels
timeFrame: At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
measure: 8-hydroxydeoxyguanosine (8-OHdG) levels
timeFrame: At induction of anesthesia TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation
measure: Mechanical ventilation
timeFrame: From ICU admission until extubation occurs, assessed daily up to 100 days from transplantation
measure: Length of Intensive Care Unit (ICU) stay
timeFrame: From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
measure: Allograft dysfunction
timeFrame: Within the first 7 days after transplantation
measure: Mortality in Intensive Care Unit (ICU)
timeFrame: From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
measure: Length of hospitalization
timeFrame: From ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantation
measure: Acute kidney injury (AKI)
timeFrame: Worst kidney function within the first 7 days after TX
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Study officials:
References:
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