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Clinical Trials/NCT03873675
NCT03873675
Completed
Not Applicable

Trends in Parathyroid Hormone Plasma Concentration in Multi-organ Failure Critically Ill Patients Undergoing Regional Citrate Anticoagulation Continuous Renal Replacement Therapies - Prospective Observational Study.

Uniwersytecki Szpital Kliniczny w Opolu3 sites in 1 country30 target enrollmentMay 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Uniwersytecki Szpital Kliniczny w Opolu
Enrollment
30
Locations
3
Primary Endpoint
The change in parathyroid hormone serum concentration during regional citrate anticoagulation continuous renal replacement therapy (CRRT) in the acute phase of critical illness.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2019
End Date
November 1, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uniwersytecki Szpital Kliniczny w Opolu
Responsible Party
Principal Investigator
Principal Investigator

Tomasz Czarnik, MD PhD

Principal Investigator

Uniwersytecki Szpital Kliniczny w Opolu

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

Outcomes

Primary Outcomes

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.

Study Sites (3)

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