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

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.

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Key information

Conditions

Multi Organ Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Shock Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu, Opole, Silesian Voivodeship, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biospecimen retention

Other

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

Primary outcomes

The relationship between vitamin D plasma levels and regional citrate CRRT

Time frame: 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.

Secondary outcomes

The relationship between other parameters of calcium-phosphate metabolism and regional citrate CRRT

Time frame: 96 hours

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.

Sponsors and collaborators

Lead sponsor

Uniwersytecki Szpital Kliniczny w Opolu

Other

Registry information

Official study 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

Acronym: VitDcrrt

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Apr 10, 2015
Registry last updated: Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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