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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Multi Organ Failure
• Intervention / Treatment: Other: biospecimen retention

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Poland
  • Silesia
    • Opole, Silesia, Poland, 45-401
      • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
    • Opole, Silesia, Poland, 45-372
      • Department of Endocrinology, Szpital Wojewodzki w Opolu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Kidney Injury - CRRT; 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. Biospecimen retention to measure vitamin D, parathormone, calcium, magnesium, phosphate, globulin, albumin plasma levels.	Other: biospecimen retention; biospecimen retention to measure vitamin D, parathormone, calcium, magnesium, phosphate, globulin, albumin plasma levels
Control; 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. Biospecimen retention to measure vitamin D, parathormone, calcium, magnesium, phosphate, globulin, albumin plasma levels.	Other: biospecimen retention; biospecimen retention to measure vitamin D, parathormone, calcium, magnesium, phosphate, globulin, albumin plasma levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Uniwersytecki Szpital Kliniczny w Opolu
• Investigators: Principal Investigator: Tomasz Czarnik, MD PhD, Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin D; Acute Kidney Injury; Critical Care; Citrate anticoagulation; Continuous Renal Replacement Therapy; Multi Organ Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Shock; Acute Kidney Injury; Multiple Organ Failure
• Other Study ID Numbers: VitaminDcitrateCRRT