Liver Failure, AcuteNCT04512014
Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery
An observational study of Liver Failure, Acute, run by Institutul Clinic Fundeni at 1 site in Romania.
Trial summary
Major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. Of these, posthepatectomy liver failure (PHLF) represents one of the most important cause of postoperative unfavourable outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Acute
- What is being tested?
- serum lactate
- How many people
- 55 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2017to 31 Dec 2019
- 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: all patients undergoing major liver failure in our institution
Who may be able to join
- patients undergoing major liver surgery for primary or secondary tumours
Who cannot join
- unsigned patient consent
- death within 24 hours
- need for perioperative renal replacement therapy
- underlying liver disease (e.g. liver cirrhosis)
- other causes of raised lactate levels (e.g. shock)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lactate Levels in as a Risk Factor for Posthepatectomy Liver Failure
Major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. Of these, posthepatectomy liver failure (PHLF) represents one of the most important cause of postoperative unfavourable outcome. The present study investigates the correlation between lactate levels and PHLF. Lactate levels were collected at six specific timepoints: preoperative, pre-dissection phase, post-dissection phase, end of surgery and 24-hours and 48-hours in the postoperative period.
- Conditions
- Liver Failure, Acute
- Being tested
- serum lactate
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum lactateDiagnostic test
perioperative measurement of lactate levels
| Study group | Role | What they receive |
|---|---|---|
| major liver surgery | Patients undergoing major liver surgery Receives: Diagnostic Test: serum lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
lactate levels (mmol/L) in patients with PHLF
correlation of lactate levels with the diagnosis of PHLF
Measured: early postoperative period (48 hours)
Secondary outcomes (1)
mortality
in hospital mortality
Measured: 30 days mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Failure, AcuteStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul Clinic Fundeni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Popescu Mihai, Institutul Clinic Fundeni
- Investigators
- Dana Tomescu, Prof, Study chair, Fundeni Clinical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512014
- Sponsor's protocol ID
- Liver_lactate
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lactate Levels in as a Risk Factor for Posthepatectomy Liver Failure
- ClinicalTrials.gov ID
- NCT04512014
- Acronym / sponsor ID
- Liver_lactate
- Conditions
- Liver Failure, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Institutul Clinic FundeniUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Aug 2020 (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.
Major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. Of these, posthepatectomy liver failure (PHLF) represents one of the most important cause of postoperative unfavourable outcome. The present study investigates the correlation between lactate levels and PHLF. Lactate levels were collected at six specific timepoints: preoperative, pre-dissection phase, post-dissection phase, end of surgery and 24-hours and 48-hours in the postoperative period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| major liver surgery | – | Diagnostic Test: serum lactatePatients undergoing major liver surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients undergoing major liver failure in our institution
Key inclusion criteria (1 listed)
- patients undergoing major liver surgery for primary or secondary tumours
Key exclusion criteria (5 listed)
- unsigned patient consent
- death within 24 hours
- need for perioperative renal replacement therapy
- underlying liver disease (e.g. liver cirrhosis)
- other causes of raised lactate levels (e.g. shock)
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 |
|---|---|---|
| serum lactateperioperative measurement of lactate levels | Diagnostic test | major liver surgery |
Primary outcome
lactate levels (mmol/L) in patients with PHLF
Time frame: early postoperative period (48 hours)
correlation of lactate levels with the diagnosis of PHLF
1 secondary outcome
mortality
Time frame: 30 days mortality
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 13 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Liver Failure, Acute
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Dana Tomescu, Prof study chair
Fundeni Clinical Institute
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 Failure, Acute, run by Institutul Clinic Fundeni at 1 site in Romania.
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 5 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 13 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 Romania. 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?
lactate levels (mmol/L) in patients with PHLF (time frame: early postoperative period (48 hours)). 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 13 Aug 2020.