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

Sponsor
Uniwersytecki Szpital Kliniczny w Opolu (Other)
Overall Status
Completed
CT.gov ID
NCT02414386
Collaborator
(none)
40
2
40.1
20
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: biospecimen retention

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Dec 4, 2018
Actual Study Completion Date :
Dec 4, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The relationship between vitamin D plasma levels and regional citrate CRRT [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Endocrinology, Szpital Wojewodzki w Opolu Opole Silesia Poland 45-372
2 Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu Opole Silesia Poland 45-401

Sponsors and Collaborators

  • Uniwersytecki Szpital Kliniczny w Opolu

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tomasz Czarnik, MD PhD, Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
ClinicalTrials.gov Identifier:
NCT02414386
Other Study ID Numbers:
  • VitaminDcitrateCRRT
First Posted:
Apr 10, 2015
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Keywords provided by Tomasz Czarnik, MD PhD, Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022