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

NCT ID: NCT02414386

Last Updated: 2022-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Multi Organ Failure Acute Kidney Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

biospecimen retention

Intervention Type OTHER

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.

biospecimen retention

Intervention Type OTHER

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

Interventions

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biospecimen retention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uniwersytecki Szpital Kliniczny w Opolu

OTHER

Sponsor Role lead

Responsible Party

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Tomasz Czarnik, MD PhD

Tomasz Czarnik, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomasz Czarnik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Endocrinology, Szpital Wojewodzki w Opolu

Opole, Silesian Voivodeship, Poland

Site Status

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

Opole, Silesian Voivodeship, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type RESULT
PMID: 33242935 (View on PubMed)

Other Identifiers

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VitaminDcitrateCRRT

Identifier Type: -

Identifier Source: org_study_id

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