Secondary HypothyroidismNCT04767763
Thyroid Function in Critically Ill Patients With Acute Kidney Injury
An observational study of Secondary Hypothyroidism, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The objective of this study was to assess the changes in thyroid hormones and its activity during CRRT in patients with Acute Kidney Injury. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Secondary Hypothyroidism
- What is being tested?
- Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- 19 Feb 2019to 1 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with acute kidney injury and indications for continuous renal replacement therapy without pre-existing end-stage chronic kidney disease or hypothyroidism.
Who may be able to join
- Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT)
Who cannot join
- Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis or with history of hypothyroidism.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship, 80-214
About this study
Official title: Association of Continuous Veno-venous Hemodiafiltration With Citrate Anticoagulation to Thyroid Function in Critically Ill Patients
The objective of this study was to assess the changes in thyroid hormones and its activity during CRRT in patients with Acute Kidney Injury.
Read the detailed description
After approval from the local Bioethics Committee of the Medical University of Gdańsk in Poland, the study was carried out between February 2019 and February 2020 among 32 patients admitted to ICU. There was no need to obtain written consent from the patients since the study was observational with no therapeutic intervention and decisional incapacity caused either by sedative drugs or severe condition of the patient.
Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT) were included to this study irrespective of their gender, race and age. Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis.
After decision to implement CRRT the serial blood samples were collected into two red-top tube (no anticoagulant or preservative) before initiation of CRRT and at 1,2,3,6,9,12,15,18-day following. Last samples were collected 3 days after the end of CRRT. Level of TSH, fT3 and fT4 were checked from the first tube after collecting the blood. Second tube was kept frozen until levels of TRH, TT3, TT4, rT3 could be measured. In all the patients high-dose continuous veno-venous hemodiafiltration (CVVHDF) with citrate anticoagulation was performed. Blood flow and dialysis dosage were the same for every patient depending on their weight. The weight was rounded up or down and patients were assigned to the nearest group.
- Conditions
- Secondary Hypothyroidism
- Being tested
- Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF
- Keywords
- renal replacement therapy, thyroid hormones, acute kidney injury, intensive care unit
- Medical subject headings
- Hypothyroidism, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDFDiagnostic test
blood samples were collected before initiation of CRRT and at 1,2,3,6,9-day following. Last samples were collected 3 days after the end of CRRT.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acute Kidney Injury | Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT) were included to this study irrespective of their gender, race and age. Receives: Diagnostic Test: Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood concentrations of thyroid hormones
TSH, fT3, fT4, TRH, TT3, TT4, rT3
Measured: Samples were collected up to 1 hour before initiation and after 24, 48, 72, 144, 216 hours after initiation of CRRT. Last sample was collected 72 hours after the end of CRRT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start19 Feb 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HypothyroidismStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767763
- Sponsor's protocol ID
- 02-0064/07/287
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: share only results
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Continuous Veno-venous Hemodiafiltration With Citrate Anticoagulation to Thyroid Function in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04767763
- Acronym / sponsor ID
- 02-0064/07/287
- Conditions
- Secondary Hypothyroidism
- Keywords
- renal replacement therapy, thyroid hormones, acute kidney injury, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 23 Feb 2021 (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 was to assess the changes in thyroid hormones and its activity during CRRT in patients with Acute Kidney Injury.
Detailed description
After approval from the local Bioethics Committee of the Medical University of Gdańsk in Poland, the study was carried out between February 2019 and February 2020 among 32 patients admitted to ICU. There was no need to obtain written consent from the patients since the study was observational with no therapeutic intervention and decisional incapacity caused either by sedative drugs or severe condition of the patient.
Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT) were included to this study irrespective of their gender, race and age. Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis.
After decision to implement CRRT the serial blood samples were collected into two red-top tube (no anticoagulant or preservative) before initiation of CRRT and at 1,2,3,6,9,12,15,18-day following. Last samples were collected 3 days after the end of CRRT. Level of TSH, fT3 and fT4 were checked from the first tube after collecting the blood. Second tube was kept frozen until levels of TRH, TT3, TT4, rT3 could be measured. In all the patients high-dose continuous veno-venous hemodiafiltration (CVVHDF) with citrate anticoagulation was performed. Blood flow and dialysis dosage were the same for every patient depending on their weight. The weight was rounded up or down and patients were assigned to the nearest group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Kidney Injury | – | Diagnostic Test: Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDFPatients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT) were included to this study irrespective of their gender, race and age. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with acute kidney injury and indications for continuous renal replacement therapy without pre-existing end-stage chronic kidney disease or hypothyroidism.
Key inclusion criteria (1 listed)
- Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT)
Key exclusion criteria (1 listed)
- Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis or with history of hypothyroidism.
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 |
|---|---|---|
| Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDFblood samples were collected before initiation of CRRT and at 1,2,3,6,9-day following. Last samples were collected 3 days after the end of CRRT. | Diagnostic test | Patients with Acute Kidney Injury |
Primary outcome
blood concentrations of thyroid hormones
Time frame: Samples were collected up to 1 hour before initiation and after 24, 48, 72, 144, 216 hours after initiation of CRRT. Last sample was collected 72 hours after the end of CRRT.
TSH, fT3, fT4, TRH, TT3, TT4, rT3
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 23 Feb 2021.
- Individual participant dataSharing planned: Undecided. share only results
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Hypothyroidism, run by Medical University of Gdansk at 1 site 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 1 inclusion and 1 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
blood concentrations of thyroid hormones (time frame: Samples were collected up to 1 hour before initiation and after 24, 48, 72, 144, 216 hours after initiation of CRRT. Last sample was collected 72 hours after the end of CRRT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.