Parathyroid Hormone Kinetics During CRRT

December 28, 2021 updated by: Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lower Silesia
      • Wrocław, Lower Silesia, Poland, 50-367
        • Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland.
    • Silesia
      • Opole, Silesia, Poland, 45-401
        • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
      • Opole, Silesia, Poland, 45-372
        • Department of Endocrinology, Szpital Wojewodzki w Opolu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniwersytecki Szpital Kliniczny w Opolu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKIparathormoneCRRTstudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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