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Completed

NCT Number: NCT04462874

Mean Systemic Filling Pressure Trends in Liver Transplant Recipients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients undergoing liver transplantation 18-65 years

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. mean systemic filling pressures(MSFP)

    Time frame: 1 day

    MSFP trends during liver transplantation, hourly

Secondary outcomes

  1. icu stay

    Time frame: 28 days

    duration of stay in the intensive care unit

  2. 28 day mortality

    Time frame: 28 days

    mortality by all causes till day 28

Other outcomes

  1. respiratory complications

    Time frame: 7 days

    number of participants needing reintubation, prolonged mechanical ventilation, intercostal drain placement

  2. acute kidney injury(AKI)

    Time frame: 7 days

    AKI incidence upto 7 days

  3. cardiac complication

    Time frame: 7 days

    number of participants with significant arrhythmias and ischemia associated with hypotension

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2020
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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