Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 109 for:    CALCIUM CATION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02414386
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu

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
Multi Organ Failure Acute Kidney Injury Other: biospecimen retention

Layout table for study information
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 : August 2015
Actual Primary Completion Date : December 4, 2018
Actual Study Completion Date : December 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414386


Locations
Layout table for location information
Poland
Department of Endocrinology, Szpital Wojewodzki w Opolu
Opole, Silesia, Poland, 45-372
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
Layout table for investigator information
Principal Investigator: Tomasz Czarnik, MD PhD Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Layout table for additonal information
Responsible Party: Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
ClinicalTrials.gov Identifier: NCT02414386     History of Changes
Other Study ID Numbers: VitaminDcitrateCRRT
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Keywords provided by Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu:
Vitamin D
Continuous Renal Replacement Therapy
Multi Organ Failure
Acute Kidney Injury
Critical Care
Citrate anticoagulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcium
Calcium-Regulating Hormones and Agents
Calcium Chelating Agents
Acute Kidney Injury
Multiple Organ Failure
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Shock
Vitamin D
Ergocalciferols
Vitamins
Citric Acid
Sodium Citrate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action