Mean Systemic Filling Pressure Trends in Liver Transplant Recipients

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462874
• Other study ID #: ILBS - Liver Transplant-4
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: December 15, 2021

Study information

• Verified date: September 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• all patients undergoing liver transplantation 18-65 years

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Liver Diseases
• Liver Transplant; Complications

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	respiratory complications	number of participants needing reintubation, prolonged mechanical ventilation, intercostal drain placement	7 days
Other	acute kidney injury(AKI)	AKI incidence upto 7 days	7 days
Other	cardiac complication	number of participants with significant arrhythmias and ischemia associated with hypotension	7 days
Primary	mean systemic filling pressures(MSFP)	MSFP trends during liver transplantation, hourly	1 day
Secondary	icu stay	duration of stay in the intensive care unit	28 days
Secondary	28 day mortality	mortality by all causes till day 28	28 days