End Stage Liver DiseasesSPPLITNCT02119585
Analysis of Respiratory System Mechanics and Inflammatory Response During Orthotopic Liver Transplantation (SPPLIT Trial)
An observational study of End Stage Liver Diseases, run by University of Turin, Italy at 1 site in Italy.
Trial summary
During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Liver Diseases
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Jan 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with end stage liver diseases undergoing to liver transplantation
Who may be able to join
- orthotopic liver transplantation
- valid informed consent
Who cannot join
- Age < 18 yrs
Trial locations and contacts
1 site in 1 country.
Vito Fanelli, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Turin, 10126
Vito Fanelli, MD, PhD, vito.fanelli@unito.it
About this study
Official title: Observational Study to Analyze Respiratory System Mechanics Changes and Inflammatory Responses During Orthotopic Liver Transplantation (SPPLIT Trial)
During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall.
We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. This impairment is associated with the systemic inflammatory response following liver reperfusion.
- Conditions
- End Stage Liver Diseases
- Keywords
- orthotopic liver transplantation, ischemia reperfusion syndrome, cytokines, respiratory system elastance, lung elastance, chest wall elastance, shunt, dead space, acute respiratory failure, atelectasis, pleural effusion
- Medical subject headings
- Pulmonary Atelectasis, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing OLT | insertion of nasogastric tube for measurements of chest wall mechanics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastance of Respiratory System, Lung and Chest Wall
Measured: at 90 minutes after liver reperfusion
Elastance of Respiratory System, Lung and Chest Wall
Measured: at 3 hours after liver reperfusion
Elastance of Respiratory System, Lung and Chest Wall
Measured: at 24 hours after liver reperfusion
Secondary outcomes (6)
Acute respiratory failure
Measured: 28 days
Ventilator free days
Measured: 28 days
ICU length of stay
Measured: 28 days
hospital length of stay
Measured: 28 days
Inflammatory mediators in plasma samples
Measured: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
Inflammatory mediators in urine samples
Measured: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseasesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vito Fanelli MD, PhD, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119585
- Sponsor's protocol ID
- 0077687
- Acronym
- SPPLIT
- Status last verified
- Dec 2014
- First submitted
- 14 Apr 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Analyze Respiratory System Mechanics Changes and Inflammatory Responses During Orthotopic Liver Transplantation (SPPLIT Trial)
- ClinicalTrials.gov ID
- NCT02119585
- Acronym / sponsor ID
- SPPLIT / 0077687
- Conditions
- End Stage Liver Diseases
- Keywords
- orthotopic liver transplantation, ischemia reperfusion syndrome, cytokines, respiratory system elastance, lung elastance, chest wall elastance, shunt, dead space
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 21 Apr 2014 (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.
During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall.
We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. This impairment is associated with the systemic inflammatory response following liver reperfusion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing OLT | – | –insertion of nasogastric tube for measurements of chest wall mechanics |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with end stage liver diseases undergoing to liver transplantation
Key inclusion criteria (2 listed)
- orthotopic liver transplantation
- valid informed consent
Key exclusion criteria (1 listed)
- Age < 18 yrs
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
Elastance of Respiratory System, Lung and Chest Wall
Time frame: at 90 minutes after liver reperfusion
Elastance of Respiratory System, Lung and Chest Wall
Time frame: at 3 hours after liver reperfusion
Elastance of Respiratory System, Lung and Chest Wall
Time frame: at 24 hours after liver reperfusion
6 secondary outcomes
Acute respiratory failure
Time frame: 28 days
Ventilator free days
Time frame: 28 days
ICU length of stay
Time frame: 28 days
hospital length of stay
Time frame: 28 days
Inflammatory mediators in plasma samples
Time frame: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
Inflammatory mediators in urine samples
Time frame: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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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.
Vito Fanelli, MD, PhD contact
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 End Stage Liver Diseases, run by University of Turin, Italy 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 2 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: status not confirmed, as of the sponsor's last update on 16 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vito Fanelli, MD, PhD (vito.fanelli@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elastance of Respiratory System, Lung and Chest Wall (time frame: at 90 minutes after liver reperfusion). The study lists 3 primary outcomes in all. 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 16 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.