Analysis of Respiratory System Mechanics and Inflammatory Response During Orthotopic Liver Transplantation (SPPLIT Trial)

Observational Study to Analyze Respiratory System Mechanics Changes and Inflammatory Responses During Orthotopic Liver Transplantation (SPPLIT Trial)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02119585

Acronym

SPPLIT

Enrollment

Registered

2014-04-21

Start date

2014-02-28

Completion date

2015-01-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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. 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* orthotopic liver transplantation * valid informed consent

Exclusion criteria

* Age \< 18 yrs

Design outcomes

Primary

Measure	Time frame
Elastance of Respiratory System, Lung and Chest Wall	at 90 minutes after liver reperfusion

Secondary

Measure	Time frame
Ventilator free days	28 days
ICU length of stay	28 days
Acute respiratory failure	28 days
Inflammatory mediators in plasma samples	baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
Inflammatory mediators in urine samples	baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
hospital length of stay	28 days

Countries

Italy

Contacts

Primary ContactVito Fanelli, MD, PhD

vito.fanelli@unito.it

Outcome results