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

Recruiting

• Conditions: Ascorbic Acid Deficiency; Transplantation

• Registration Number: NCT06395259
• Lead Sponsor: Policlinico Hospital

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

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-01-24
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-02
• Last Update Posted: 2024-05-02
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• Minor patients
• Multi-organ transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ascorbic Acid levels	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 Outcome Measures

Name	Time	Method
Total Antioxidant Capacity (TAC) levels	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
8-hydroxydeoxyguanosine (8-OHdG) levels	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
Length of Intensive Care Unit (ICU) stay	From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation	Length of ICU stay
Mortality in Intensive Care Unit (ICU)	From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation	Incidence of death for any cause during ICU stay
Mechanical ventilation	From ICU admission until extubation occurs, assessed daily up to 100 days from transplantation	Duration of mechanical ventilation (days) until extubation of the recipient
Allograft dysfunction	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)
Reactive Oxygen Species (ROS) levels	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
Acute kidney injury (AKI)	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
Length of hospitalization	From ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantation	Length of stay in hospital (days)

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano; 🇮🇹 Milan, Italy