Clinical trial NCT03873675: Parathyroid Hormone Kinetics During CRRT
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Multi Organ Failure
Renal Failure
Circulatory Failure
Respiratory Failure
Keywords: acute kidney injury
parathyroid hormone
continuous renal replacement therapy
citrate anticoagulation
intensive care
Lead sponsor: Uniwersytecki Szpital Kliniczny w Opolu
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: The change in parathyroid hormone serum concentration during regional citrate anticoagulation continuous renal replacement therapy (CRRT) in the acute phase of critical illness.
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland.
state: Lower Silesia
city: Opole
country: Poland
facility: Department of Endocrinology, Szpital Wojewodzki w Opolu
state: Silesia
city: Opole
country: Poland
facility: Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
state: Silesia
Study officials:
References:
citation: Czarnik A, Gawda R, Piwoda M, Marszalski M, Molsa M, Pietka M, Bolanowski M, Czarnik T. Parathyroid hormone serum concentration kinetic profile in critically ill patients undergoing continuous renal replacement therapies: a prospective observational study. Endokrynol Pol. 2021;72(4):329-335. doi: 10.5603/EP.a2021.0034. Epub 2021 May 19.