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Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study

NCT03234218 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2018-05-23

No results posted yet for this study

Summary

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,

Conditions

  • Liver Transplant Disorder
  • Vitamin D Deficiency

Sponsors & Collaborators

  • The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

    lead OTHER

Principal Investigators

  • Gennaro Martucci, MD · The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234218 on ClinicalTrials.gov