Serum Vitamin D Levels in Critically Ill Patients Undergoing Regional Citrate Anticoagulation CRRT

Acute Kidney Injury Clinical Trial

— VitDcrrt  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414386
• Other study ID #: VitaminDcitrateCRRT
• Status: Completed
• Start date: August 2015
• Est. completion date: December 4, 2018

Study information

• Verified date: December 2021
• Source: Uniwersytecki Szpital Kliniczny w Opolu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 4, 2018
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Multi Organ Failure
• Multiple Organ Failure

Intervention

Other:
• biospecimen retention
biospecimen retention to measure vitamin D, parathormone, calcium, magnesium, phosphate, globulin, albumin plasma levels

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu	Opole	Silesia
Poland	Department of Endocrinology, Szpital Wojewodzki w Opolu	Opole	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Uniwersytecki Szpital Kliniczny w Opolu

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relationship between vitamin D plasma levels and regional citrate CRRT	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.	96 hours
Secondary	The relationship between other parameters of calcium-phosphate metabolism and regional citrate CRRT	The first parathormone, total and ionized calcium, phosphate, magnesium plasma levels measurement at admission, before the start of CRRT (the zero point) Next measurements every 12 hours. Minimal number of measurements - 4, maximal - 8.; The albumin and globulin plasma levels measurements at admission and at the last measurement.	96 hours