Mean Systemic Filling Pressure Trends in Liver Transplant Recipients

NCT04462874 | Completed DMC

• 1 other identifier: ILBS - Liver Transplant-4
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications; Liver Diseases; Hemodynamic Instability

Keywords

liver transplantation; mean systemic filling pressure; advanced hemodynamic monitoring; liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• mean systemic filling pressures(MSFP)

  MSFP trends during liver transplantation, hourly

  1 day

Secondary Outcomes (2)

• icu stay

  28 days

• 28 day mortality

  28 days

Other Outcomes (3)

• respiratory complications

  7 days

• acute kidney injury(AKI)

  7 days

• cardiac complication

  7 days

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with liver diseases undergoing liver transplantation

You may qualify if:

• all patients undergoing liver transplantation 18-65 years

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karthik T Ponnappan

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 8, 2020
• Study Start: July 15, 2020
• Primary Completion: August 15, 2021
• Study Completion: December 15, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-09

Locations

IN (1)