Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Describe and explore the level and the trend of vitamin D levels in liver transplantation recipients during the first 28 days after transplantation.
研究概览
简要总结
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,
详细描述
BACKGROUND Interest in vitamin D has seen an unprecedented revival sparked by the finding that vitamin D has pleiotropic effects. The nuclear vitamin D receptor (VDR) is widely present in different cell types and organs and regulates more than 200 genes.
The link between vitamin D and critical illness is new, but intriguing, because vitamin D deficiency
- has a very high prevalence in the ICU
- is strongly associated with excess morbidity and mortality
- is associated with increased susceptibility to sepsis thought its immunomodulating effects
- has a relation with acute kidney injury, acute respiratory failure, duration of mechanical ventilation and ARDS Critically ill patients are at high risk of mortality and standard care uses little or no vitamin D.
It may well be the case that vitamin D deficiency is indeed an "invisible accomplice to morbidity and mortality," as proposed by Paul Lee.
VITAMIN D IN PATIENTS WITH CHRONIC LIVER DISEASE AND/OR CIRRHOSIS 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All recipients of liver transplantation at Ismett, aged 18 or more
排除标准
- •Lack of informed consent for the treatment of personal data. otherwise all the patients will be included if the accept to sign the informed consent
结局指标
主要结局
Describe and explore the level and the trend of vitamin D levels in liver transplantation recipients during the first 28 days after transplantation.
时间窗: Preoperative and on the post-operative day 28
Change of the Vitamin D level during the first 28 days after liver transplantation
次要结局
- Explore the association between vitamin D level and critical condition;(Post-operative day 28)
- Explore the association between pre-transplant vitamin D level and outcome(Post-operative day 28)
- Explore the association between vitamin D level and graft function(Post-operative day 28)
- Explore the association between vitamin d level and incidence of early post-operative infections(Post.operative day 28)