Clinical trial NCT02414386: Serum Vitamin D Levels in Critically Ill Patients Undergoing Regional Citrate Anticoagulation CRRT
Official title: Serum Vitamin D Levels in Multi-organ Failure Critically Ill Patients Undergoing Regional Citrate Anticoagulation Continuous Renal Replacement Therapies - Prospective Observational Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multi Organ Failure
Acute Kidney Injury
Keywords: Vitamin D
Continuous Renal Replacement Therapy
Multi Organ Failure
Acute Kidney Injury
Critical Care
Citrate anticoagulation
Lead sponsor: Uniwersytecki Szpital Kliniczny w Opolu
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute Kidney Injury - CRRT group: Multi-organ failure with acute kidney injury 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). Multi-organ failure is defined as a respiratory, circulatory and renal failure.

Control group: Multi-organ failure non acute kidney injury critically ill patients admitted to the critical care unit. Multi-organ failure is defined as a respiratory and circulatory failure.

All patients: machanically ventilated.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: The relationship between vitamin D plasma levels and regional citrate CRRT
timeFrame: 96 hours
Secondary outcomes:
measure: The relationship between other parameters of calcium-phosphate metabolism and regional citrate CRRT
timeFrame: 96 hours
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Department of Endocrinology, Szpital Wojewodzki w Opolu
state: Silesia
city: Opole
country: Poland
facility: Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
state: Silesia
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
name: Tomasz Czarnik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Czarnik T, Czarnik A, Gawda R, Piwoda M, Marszalski M, Czuczwar M. Vitamin D serum levels in multiorgan failure critically ill patients undergoing continuous renal replacement therapies. Anaesthesiol Intensive Ther. 2020;52(5):359-365. doi: 10.5114/ait.2020.101008.