Parathyroid Hormone Kinetics During CRRT

Sponsor
Uniwersytecki Szpital Kliniczny w Opolu (Other)
Overall Status
Completed
CT.gov ID
NCT03873675
Collaborator
(none)
30
3
17.9
10
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: parathyroid hormone

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
May 6, 2019
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Study group

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.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland. Wrocław Lower Silesia Poland 50-367
2 Department of Endocrinology, Szpital Wojewodzki w Opolu Opole Silesia Poland 45-372
3 Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu Opole Silesia Poland 45-401

Sponsors and Collaborators

  • Uniwersytecki Szpital Kliniczny w Opolu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tomasz Czarnik, MD PhD, Principal Investigator, Uniwersytecki Szpital Kliniczny w Opolu
ClinicalTrials.gov Identifier:
NCT03873675
Other Study ID Numbers:
  • AKIparathormoneCRRTstudy
First Posted:
Mar 13, 2019
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tomasz Czarnik, MD PhD, Principal Investigator, Uniwersytecki Szpital Kliniczny w Opolu
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022