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

NCT02414386 | Completed

• 1 other identifier: VitaminDcitrateCRRT
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Multi Organ Failure; Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  96 hours

Study Arms (2)

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

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

Interventions

biospecimen retention OTHER

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

Acute Kidney Injury - CRRT; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniwersytecki Szpital Kliniczny w Opolu: lead

Study Sites (2)

Department of Endocrinology, Szpital Wojewodzki w Opolu

Opole, Silesian Voivodeship, 45-372, Poland

Location

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Opole, Silesian Voivodeship, 45-401, Poland

Location

Related 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.2020.101008.

  PMID: 33242935 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood samples taken from the arterial catheter every 12 hours to obtain vitamin D, parathormon, calcium, magnesium, phosphate, globulin, albumin plasma levels

MeSH Terms

Conditions

Multiple Organ Failure; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tomasz Czarnik, MD PhD

  Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tomasz Czarnik, MD PhD

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: August 1, 2015
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

PL (2)