Liver CirrhosisNCT03587623
Copeptin Serum Level in Liver Transplant Recipients
An observational study of Liver Cirrhosis and Copeptin, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study aim is to measure perioperative copeptin concentration in blood of liver transplant recipients and to assess whether there is a correlation between its level and hemodynamic derangement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Copeptin, Liver Transplant
- How many people
- 38 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jul 2018to 31 Jan 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: Patients undergoing liver transplant
Who may be able to join
- Patient undergoing liver transplantation
Who cannot join
- Serum creatinine > 1,5 mg/dl
- Retransplantation
- Patient refusal
- CRRT or dialysis preoperatively
Trial locations and contacts
1 site in 1 country.
About this study
The study aim is to measure perioperative copeptin concentration in blood of liver transplant recipients and to assess whether there is a correlation between its level and hemodynamic derangement.
- Conditions
- Liver Cirrhosis, Copeptin, Liver Transplant
- Medical subject headings
- Liver Cirrhosis, Diabetes Insipidus
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Copeptin concentration
Measured: Baseline, intraoperatively, 1,3,7,21 day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start4 Jul 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beata Błaszczyk, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587623
- Sponsor's protocol ID
- Livercopeptin
- Status last verified
- Aug 2020
- First submitted
- 3 Jul 2018
- Last updated
- 19 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin Serum Level in Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT03587623
- Acronym / sponsor ID
- Livercopeptin
- Conditions
- Liver Cirrhosis, Copeptin, Liver Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 16 Jul 2018 (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 study aim is to measure perioperative copeptin concentration in blood of liver transplant recipients and to assess whether there is a correlation between its level and hemodynamic derangement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver transplant
Key inclusion criteria (1 listed)
- Patient undergoing liver transplantation
Key exclusion criteria (4 listed)
- Serum creatinine > 1,5 mg/dl
- Retransplantation
- Patient refusal
- CRRT or dialysis preoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Copeptin concentration
Time frame: Baseline, intraoperatively, 1,3,7,21 day postoperatively
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 19 Aug 2020.
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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 Liver Cirrhosis and Copeptin, run by Medical University of Warsaw 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 4 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 19 Aug 2020. 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?
Serum Copeptin concentration (time frame: Baseline, intraoperatively, 1,3,7,21 day postoperatively). 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 19 Aug 2020.