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Completed

NCT Number: NCT03873675

Parathyroid Hormone Kinetics During CRRT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland., Wroclaw, Lower Silesian Voivodeship, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parathyroid hormone

Diagnostic Test

10-20ml blood samples taken from the arterial catheter every 12 hours to obtain parathyroid hormone serum concentration. 6-8 samples per patient

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Uniwersytecki Szpital Kliniczny w Opolu

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2019
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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