Mean Systemic Filling Pressure Trends in Liver Transplant Recipients

Mean Systemic Filling Pressure Trends in Liver Transplant Recipients - a Prospective Observational Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Liver Transplant; Complications; Hemodynamic Instability

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with liver diseases undergoing liver transplantation

Description

Inclusion Criteria:

• all patients undergoing liver transplantation 18-65 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean systemic filling pressures(MSFP)	MSFP trends during liver transplantation, hourly	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
icu stay	duration of stay in the intensive care unit	28 days
28 day mortality	mortality by all causes till day 28	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory complications	number of participants needing reintubation, prolonged mechanical ventilation, intercostal drain placement	7 days
acute kidney injury(AKI)	AKI incidence upto 7 days	7 days
cardiac complication	number of participants with significant arrhythmias and ischemia associated with hypotension	7 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Karthik T Ponnappan, Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: liver transplantation; liver cirrhosis; mean systemic filling pressure; advanced hemodynamic monitoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ILBS - Liver Transplant-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No