Parathyroid Hormone Kinetics During CRRT

Completed

• Conditions: Critical Illness; Multi Organ Failure; Renal Failure; Circulatory Failure; Respiratory Failure
• Interventions: Diagnostic Test: parathyroid hormone

• Registration Number: NCT03873675
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Study Start: 2019-05-06
• Primary Completion: 2020-10-01
• Study Completion: 2020-11-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	parathyroid hormone	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.

Primary Outcome Measures

Name	Time	Method
The change in parathyroid hormone serum concentration during regional citrate anticoagulation continuous renal replacement therapy (CRRT) in the acute phase of critical illness.	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.

Trial Locations

Locations (3)

Department of Endocrinology, Szpital Wojewodzki w Opolu; 🇵🇱 Opole, Silesia, Poland

Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland.; 🇵🇱 Wrocław, Lower Silesia, Poland

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu; 🇵🇱 Opole, Silesia, Poland