An observational study in Transplantation and Ascorbic Acid Deficiency, sponsored by Policlinico Hospital. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Policlinico Hospital · Observational
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:
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
26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 13 observational studies indexed under Primary Graft Dysfunction.
Browse Primary Graft Dysfunction studies →Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing liver, lungs or kidneys transplantation at Ospedale Maggiore in Milan. There is no control group
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who at the end of surgery have sub-optimal plasma ascorbic acid levels, i.e. with concentrations lower than 28 µmol/L
Patients who at the end of surgery have plasma ascorbic acid levels equal to or greater than 28 µmol/L
Ascorbic Acid levels
Quantification of plasma ascorbic acid levels before and after liver/kidney/lung transplantation
Time frame: At induction of anesthesia for TX, within 24h from ICU admission, 72 hours after transplantation, 7 days after transplantation
Reactive Oxygen Species (ROS) levels
Quantification of ROS before and after liver/kidney/lung transplantation
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
Quantification of TAC before and after liver/kidney/lung transplantation
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
Quantification of 8-OHdG before and after liver/kidney/lung transplantation
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Within the first 7 days after transplantation
Mortality in Intensive Care Unit (ICU)
Incidence of death for any cause during ICU stay
Time frame: From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation
Length of hospitalization
Length of stay in hospital (days)
Time frame: 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
Time frame: Worst kidney function within the first 7 days after TX
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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