NCT03873675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

March 11, 2019

Last Update Submit

December 28, 2021

Conditions

Critical IllnessMulti Organ FailureRenal FailureCirculatory FailureRespiratory Failure

Keywords

acute kidney injuryparathyroid hormonecontinuous renal replacement therapycitrate anticoagulationintensive care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

parathyroid hormoneDIAGNOSTIC_TEST

10-20ml blood samples taken from the arterial catheter every 12 hours to obtain parathyroid hormone serum concentration. 6-8 samples per patient

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland.

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

Location

Department of Endocrinology, Szpital Wojewodzki w Opolu

Opole, Silesian Voivodeship, 45-372, Poland

Location

Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Opole, Silesian Voivodeship, 45-401, Poland

Location

Related 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. Endokrynol Pol. 2021;72(4):329-335. doi: 10.5603/EP.a2021.0034. Epub 2021 May 19.

    PMID: 34010434RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood samples (10-20ml) taken from the arterial catheter every 12 hours

MeSH Terms

Conditions

Critical IllnessMultiple Organ FailureRenal InsufficiencyShockRespiratory InsufficiencyAcute Kidney Injury

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

May 6, 2019

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

January 14, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

PL(3)