跳至主要内容
临床试验/NCT02414386
NCT02414386已完成不适用

Serum Vitamin D Levels in Multi-organ Failure Critically Ill Patients Undergoing Regional Citrate Anticoagulation Continuous Renal Replacement Therapies - Prospective Observational Case-control Study

Uniwersytecki Szpital Kliniczny w Opolu2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
The relationship between vitamin D plasma levels and regional citrate CRRT

研究概览

简要总结

Several studies point at a potential relationship between vitamin D deficiency and worse outcome in critically ill patients admitted to the intensive care unit. It is linked with the lack of vitamin D pleiotropic effects in the state of hypovitaminosis D. The pleiotropism of vitamin D is dependent on a specific feature of vitamin D receptor (VDR) namely polymorphism and its universal existence in the human body. Vitamin D pleiotropism is linked with cancer cells inhibition, a modulation of the immune system, an influence on cardiovascular system and neuroprotection.

In 35-65% critically ill patients hospitalized in the intensive care unit the acute kidney injury (AKI) is diagnosed. Acute kidney injury increases significantly the probability of death. The standard therapy of a severe AKI in many intensive care units is the regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (CVVHDF). The specificity of the regional citrate anticoagulation by means of precise ionized calcium and citrate dosing evokes questions regarding its influence on vitamin D and entire calcium-phosphate metabolism in the state of a severe AKI treated with regional citrate anticoagulation continuous renal replacement therapy.

The intention of that trial is to measure vitamin D plasma levels and other parameters (parathormone, ionized and total calcium, magnesium, phosphate, albumin, globulin) linked with calcium-phosphate metabolism in the human body. We would like to assess potential relationships between the regional citrate anticoagulation continuous renal replacement therapy and these parameters.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Respiratory, circulatory failure and acute kidney injury mechanically ventilated critically ill patients admitted to the critical care unit undergoing regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (CVVHDF)

排除标准

  • age less than 18 years
  • acute liver failure
  • hypercalcemia at admission (total calcium plasma level > 10.6 mg/dL; total ionized calcium plasma level > 1.35 mmol/L)
  • parathyroid glands disease at admission
  • serum vitamin D level < 10 ng/ml at admission
  • end stage renal disease at admission
  • lack of relatives consent

结局指标

主要结局

The relationship between vitamin D plasma levels and regional citrate CRRT

时间窗: 96 hours

The first vitamin D plasma level measurement at admission, before the start of CRRT (the zero point) Next vitamin D plasma level measurements every 12 hours. Minimal number of measurements - 6, maximal - 8.

次要结局

  • The relationship between other parameters of calcium-phosphate metabolism and regional citrate CRRT(96 hours)

研究者

发起方
Uniwersytecki Szpital Kliniczny w Opolu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomasz Czarnik, MD PhD

Tomasz Czarnik, MD PhD

Uniwersytecki Szpital Kliniczny w Opolu

研究点 (2)

Loading locations...

相似试验