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Trial record 31 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Parathyroid Hormone Kinetics During CRRT

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ClinicalTrials.gov Identifier: NCT03873675
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu

Brief Summary:
The objective of this study is to assess the parathyroid hormone serum concentrations and kinetics in critically ill patients admitted to the intensive care unit due to multi-organ failure and undergoing citrate anticoagulation continuous renal replacement therapy.

Condition or disease Intervention/treatment
Critical Illness Multi Organ Failure Renal Failure Circulatory Failure Respiratory Failure Diagnostic Test: parathyroid hormone

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trends in Parathyroid Hormone Plasma Concentration in Multi-organ Failure Critically Ill Patients Undergoing Regional Citrate Anticoagulation Continuous Renal Replacement Therapies - Prospective Observational Study.
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort Intervention/treatment
Study group
Multi-organ failure with acute kidney injury critically ill patients admitted to the intensive 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.
Diagnostic Test: parathyroid hormone
10-20ml blood samples taken from the arterial catheter every 12 hours to obtain parathyroid hormone serum concentration. 6-8 samples per patient




Primary Outcome Measures :
  1. The change in parathyroid hormone serum concentration during regional citrate anticoagulation continuous renal replacement therapy (CRRT) in the acute phase of critical illness. [ Time Frame: 96 hours ]
    The first parathyroid hormone serum level will be measured before the start of CRRT (the zero point) Next measurements will be performed every 12 hours. Minimal number of measurements - 6, maximal - 8 per patient.


Biospecimen Retention:   Samples With DNA
blood samples (10-20ml) taken from the arterial catheter every 12 hours


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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
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.
Criteria

Inclusion Criteria:

  • Acute respiratory failure
  • Acute circulatory failure
  • acute kidney injury treated with regional citrate anticoagulation continuous renal replacement therapy by means of continuous veno-venous hemodiafiltration (CVVHDF
  • continuous renal replacement therapy started no later than 48 hours after admission
  • SOFA score 5 or more

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
  • end stage renal disease
  • therapeutic plasma exchange
  • extracorporeal membrane oxygenation
  • unfavorable outcome (death) predicted within 72 hours (as assessed by investigator)
  • 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): NCT03873675


Contacts
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Contact: Tomasz Czarnik, MD PhD 0048669906333 tczarnik@mac.com

Locations
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Poland
Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland. Not yet recruiting
Wrocław, Lower Silesia, Poland, 50-367
Contact: Marek Bolanowski, MD PhD         
Department of Endocrinology, Szpital Wojewodzki w Opolu Not yet recruiting
Opole, Silesia, Poland, 45-372
Contact: Aneta Czarnik, MD    0048600210054    anetaczarnik@icloud.com   
Principal Investigator: Aneta Czarnik, MD         
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu Recruiting
Opole, Silesia, Poland, 45-401
Contact: Tomasz Czarnik, MD PhD    0048669906333    tczarnik@mac.com   
Principal Investigator: Tomasz Czarnik, MD PhD         
Sub-Investigator: Ryszard Gawda, MD PhD         
Sponsors and Collaborators
Uniwersytecki Szpital Kliniczny w Opolu

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Responsible Party: Tomasz Czarnik, MD PhD, Principal Investigator, Uniwersytecki Szpital Kliniczny w Opolu
ClinicalTrials.gov Identifier: NCT03873675     History of Changes
Other Study ID Numbers: AKIparathormoneCRRTstudy
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu:
acute kidney injury
parathyroid hormone
continuous renal replacement therapy
citrate anticoagulation
intensive care
Additional relevant MeSH terms:
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Shock
Respiratory Insufficiency
Critical Illness
Multiple Organ Failure
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Citric Acid
Hormones
Parathyroid Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents