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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02414386
Acronym
VitDcrrt
Enrollment
40
Registered
2015-04-10
Start date
2015-08-31
Completion date
2018-12-04
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Multi Organ Failure

Keywords

Vitamin D, Continuous Renal Replacement Therapy, Multi Organ Failure, Acute Kidney Injury, Critical Care, Citrate anticoagulation

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.

Interventions

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

Sponsors

Uniwersytecki Szpital Kliniczny w Opolu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The relationship between vitamin D plasma levels and regional citrate CRRT96 hoursThe 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.

Secondary

MeasureTime frameDescription
The relationship between other parameters of calcium-phosphate metabolism and regional citrate CRRT96 hoursThe 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026