Critical IllnessNCT03873675
Parathyroid Hormone Kinetics During CRRT
An observational study of Critical Illness and Multi Organ Failure, run by Uniwersytecki Szpital Kliniczny w Opolu at 3 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Multi Organ Failure, Renal Failure
- What is being tested?
- parathyroid hormone
- How many people
- 30 participants
- Where
- 3 sitesPoland
- Study dates
- 6 May 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- extracorporeal membrane oxygenation
- unfavorable outcome (death) predicted within 72 hours (as assessed by investigator)
- lack of relatives consent
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Department of Endocrinology, Szpital Wojewodzki w Opolu
Opole, Silesian Voivodeship, 45-372
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Opole, Silesian Voivodeship, 45-401
Department of Endocrinology, Diabetology and Isotope Therapy, Wroclaw Medical University, Poland.
Wroclaw, Lower Silesian Voivodeship, 50-367
About this study
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.
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.
- Conditions
- Critical Illness, Multi Organ Failure, Renal Failure, Circulatory Failure, Respiratory Failure
- Being tested
- parathyroid hormone
- Keywords
- acute kidney injury, parathyroid hormone, continuous renal replacement therapy, citrate anticoagulation, intensive care
- Medical subject headings
- Critical Illness, Multiple Organ Failure, Renal Insufficiency, Shock, Respiratory Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: parathyroid hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start6 May 2019
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w Opolu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873675
- Sponsor's protocol ID
- AKIparathormoneCRRTstudy
- Status last verified
- Dec 2021
- First submitted
- 11 Mar 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34010434
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03873675
- Acronym / sponsor ID
- AKIparathormoneCRRTstudy
- Conditions
- Critical Illness, Multi Organ Failure, Renal Failure, Circulatory Failure, Respiratory Failure
- Keywords
- acute kidney injury, parathyroid hormone, continuous renal replacement therapy, citrate anticoagulation, intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: parathyroid hormoneMulti-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroid hormone10-20ml blood samples taken from the arterial catheter every 12 hours to obtain parathyroid hormone serum concentration. 6-8 samples per patient | Diagnostic test | Study group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Results publication: PubMed 34010434Czarnik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Multi Organ Failure, run by Uniwersytecki Szpital Kliniczny w Opolu at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03873675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.