Parathyroid Hormone Kinetics During CRRT

Critical Illness Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873675
• Other study ID #: AKIparathormoneCRRTstudy
• Status: Completed
• Start date: May 6, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2021
• Source: Uniwersytecki Szpital Kliniczny w Opolu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulatory Failure
• Critical Illness
• Multi Organ Failure
• Multiple Organ Failure
• Renal Failure
• Respiratory Failure
• Respiratory Insufficiency
• Shock

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu	Opole	Silesia
Poland	Department of Endocrinology, Szpital Wojewodzki w Opolu	Opole	Silesia
Poland	Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland.	Wroclaw	Lower Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Uniwersytecki Szpital Kliniczny w Opolu

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in parathyroid hormone serum concentration during regional citrate anticoagulation continuous renal replacement therapy (CRRT) in the acute phase of critical illness.	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.	96 hours