Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study (D-LIVER-X)
|ClinicalTrials.gov Identifier: NCT03234218|
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : May 23, 2018
Interest in vitamin D has seen an unprecedented revival sparked by the finding that vitamin D has pleiotropic effects with an intriguing link to the critically ill patients. The recent VITdAL-ICU RCT found a significant difference in mortality in patients with severe deficiency when high doses of vitamin D supplementation were administered.
Vitamin D deficiency is extremely common in patients with chronic liver disease and/or cirrhosis. It seems to be a marker of severity of the disease, but also a possible contributing factor in determining poor outcomes.
Design of the study: Observational prospective study. Primary variable end point: Vitamin D at baseline, and POD (post-operative day) 1, 3, 7, 28.
Secondary variable end points: ICU length of stay; SAPS 2 and SOFA score at POD 1, 7; Days of mechanical ventilation; Hospital length of stay; Mortality at POD 28; Diagnosed invasive infections; Graft rejection in the first 28 days; Bilirubin and INR at POD 7 and 28.
SAFETY. The patient will not undergo to additional procedure during the study and will be asked for consent to treatment of personal data.
SAMPLE SIZE. Because of the lack of knowledge in this specific cohort no formal sample was calculated beforehand. The sample size will be defined by one-year clinical activity: about 60 consecutive patients.
STATISTICAL ANALYSIS. All statistical analysis and results will be assessed and reported as exploratory analysis. In order to describe the trend over time of the vitamin D levels, descriptive statistics such as mean, median, interquartile range and standard deviation will be evaluated. In addition, 95% confidence intervals for mean and standard deviation will be reported. Comparisons between two temporal observations will be assessed with paired t-test. Any univariate association between factors or covariates, will be explored. Statistical analyses will be done with SAS 9.4,
|Condition or disease|
|Liver Transplant Disorder Vitamin D Deficiency|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Official Title:||Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study|
|Actual Study Start Date :||September 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
- Describe and explore the level and the trend of vitamin D levels in liver transplantation recipients during the first 28 days after transplantation. [ Time Frame: Preoperative and on the post-operative day 28 ]Change of the Vitamin D level during the first 28 days after liver transplantation
- Explore the association between vitamin D level and critical condition; [ Time Frame: Post-operative day 28 ]ICU length of stay
- Explore the association between pre-transplant vitamin D level and outcome [ Time Frame: Post-operative day 28 ]Mortality at Post-Operative Day 28
- Explore the association between vitamin D level and graft function [ Time Frame: Post-operative day 28 ]Graft rejection in the first 28 days
- Explore the association between vitamin d level and incidence of early post-operative infections [ Time Frame: Post.operative day 28 ]Diagnosed invasive infections
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234218
|Palermo, Italy, 90133|
|Principal Investigator:||Gennaro Martucci, MD||The Mediterranean Institute for Transplantation and Advanced Specialized Therapies|