Lactase PersistenceNCT02565329
Serum Lactate Trend in Liver Resection
An observational study of Lactase Persistence, run by University of Milan at 1 site in Italy.
Trial summary
The study aimed to evaluate the correlation between the serum lactate concentration ed cumulative Pringle time after liver resection. In addition, the correlation between lactate clearance and clamping time was investigated. Read more about this study
- Who is it for?
- Ages 34 to 85 years
- Conditions the study is for
- Lactase Persistence
- How many people
- 133 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Feb 2015
- 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 34 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 133 consecutive patients scheduled for liver resection for primary and secondary tumors
Who may be able to join
- Patients scheduled for liver resection for hepatic tumors
Who cannot join
- Patients who received blood transfusion or affected by chronic renal failure were excluded
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan
Rozzano, Milan, 20089
About this study
Official title: Serum Lactate Trend in Liver Resection With Intermittent Pringle Maneuver: The "Square-Root" Shape
The study aimed to evaluate the correlation between the serum lactate concentration ed cumulative Pringle time after liver resection. In addition, the correlation between lactate clearance and clamping time was investigated.
Read the detailed description
During liver resection high serum lactate (sLac) concentration can be related to several clinical factors: impairment in lactate metabolism (i.e. extraction and utilization by the liver) or overproduction by splanchnic tissues; restrictive fluid regimen in order to limit the intraoperative back-flow bleeding; ischemia-reperfusion syndrome. However, the Pringle maneuver (temporary clamping of the hepatic hilum) seems having a sensible effect in inducing a significant increase in sLac levels during liver resection, particularly in the event of compromised liver function such as in cirrhosis.
Although the peak of sLac concentration may correlate with outcome, the lactate clearance (cLac) seems to be a better predictor. To date, this relationship has been mainly demonstrated in severe sepsis and shock septic. However, the effective correlation between the cumulative clamping time and cLac has not been clearly investigated. The correlation between cumulative hepatic ischemic time and sLac trend in the perioperative period after liver resection with intermittent PM was investigated.
- Conditions
- Lactase Persistence
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lactate concentration trend after liver resection
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactase PersistenceStudies 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
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
- Investigators
- Guido Guido, Guido, Principal investigator, Humanitas Research Hospital, Humanitas University, via Manzoni 56, 20089 Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565329
- Sponsor's protocol ID
- LacClearance
- Status last verified
- Sep 2015
- First submitted
- 23 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Lactate Trend in Liver Resection With Intermittent Pringle Maneuver: The "Square-Root" Shape
- ClinicalTrials.gov ID
- NCT02565329
- Acronym / sponsor ID
- LacClearance
- Conditions
- Lactase Persistence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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 aimed to evaluate the correlation between the serum lactate concentration ed cumulative Pringle time after liver resection. In addition, the correlation between lactate clearance and clamping time was investigated.
Detailed description
During liver resection high serum lactate (sLac) concentration can be related to several clinical factors: impairment in lactate metabolism (i.e. extraction and utilization by the liver) or overproduction by splanchnic tissues; restrictive fluid regimen in order to limit the intraoperative back-flow bleeding; ischemia-reperfusion syndrome. However, the Pringle maneuver (temporary clamping of the hepatic hilum) seems having a sensible effect in inducing a significant increase in sLac levels during liver resection, particularly in the event of compromised liver function such as in cirrhosis.
Although the peak of sLac concentration may correlate with outcome, the lactate clearance (cLac) seems to be a better predictor. To date, this relationship has been mainly demonstrated in severe sepsis and shock septic. However, the effective correlation between the cumulative clamping time and cLac has not been clearly investigated. The correlation between cumulative hepatic ischemic time and sLac trend in the perioperative period after liver resection with intermittent PM was investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 34 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 133 consecutive patients scheduled for liver resection for primary and secondary tumors
Key inclusion criteria (1 listed)
- Patients scheduled for liver resection for hepatic tumors
Key exclusion criteria (1 listed)
- Patients who received blood transfusion or affected by chronic renal failure were excluded
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 lactate concentration trend after liver resection
Time frame: within the first 30 days after surgery
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 1 Oct 2015.
Related trials for Lactase Persistence
Recruiting
Milk for Diabetes Prevention
Lactose Intolerance, Lactose Intolerant
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.
Guido Guido, Guido principal investigator
Humanitas Research Hospital, Humanitas University, via Manzoni 56, 20089 Milan
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 Lactase Persistence, run by University of Milan at 1 site in Italy.
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 1 Oct 2015. 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 Italy. 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 lactate concentration trend after liver resection (time frame: within the first 30 days after surgery). 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 1 Oct 2015.