Clinical trial NCT04462874: Mean Systemic Filling Pressure Trends in Liver Transplant Recipients
Official title: Mean Systemic Filling Pressure Trends in Liver Transplant Recipients - a Prospective Observational Pilot Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Liver Diseases
Hemodynamic Instability
Keywords: liver transplantation
mean systemic filling pressure
advanced hemodynamic monitoring
liver cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with liver diseases undergoing liver transplantation

Brief summary: Patients with end stage liver disease undergoing liver transplantation have varying degrees of intraoperative haemodynamic unstability during various phases of transplantation. It is difficult to determine the cause for hemodynamic instability in these patients and to predict the best treatments. Currently, cardiovascular resuscitation options are triggered by arterial pressure and cardiac output (CO) measures, focusing on the oxygen delivery side of the circulation. The primary determinants of cardiac output reside on the venous side. Veins are 30-50 times more compliant than arteries and contain approximately 75% of the total blood volume. Mean systemic filling pressure provides vital information on this venous side of the circulation. Mean systemic filling pressure , which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. We would study the Mean systemic filling pressure in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 7 days for respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between Mean systemic filling pressure and these outcomes will be analyzed.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing liver transplantation 18-65 years

Exclusion Criteria:

* pregnant patients acute liver failure, acute on chronic liver failure

Primary outcomes:
measure: mean systemic filling pressures(MSFP)
timeFrame: 1 day
Secondary outcomes:
measure: icu stay
timeFrame: 28 days
measure: 28 day mortality
timeFrame: 28 days
Other outcomes:
measure: respiratory complications
timeFrame: 7 days
measure: acute kidney injury(AKI)
timeFrame: 7 days
measure: cardiac complication
timeFrame: 7 days
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Karthik T Ponnappan
role: PRINCIPAL_INVESTIGATOR
References: