Liver Transplant; ComplicationsNCT04462874
Mean Systemic Filling Pressure Trends in Liver Transplant Recipients
An observational study of Liver Transplant; Complications and Liver Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant; Complications, Liver Diseases, Hemodynamic Instability
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jul 2020to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with liver diseases undergoing liver transplantation
Who may be able to join
- all patients undergoing liver transplantation 18-65 years
Who cannot join
- pregnant patients acute liver failure, acute on chronic liver failure
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: 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.
- Keywords
- liver transplantation, mean systemic filling pressure, advanced hemodynamic monitoring, liver cirrhosis
- Medical subject headings
- Liver Diseases, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
mean systemic filling pressures(MSFP)
MSFP trends during liver transplantation, hourly
Measured: 1 day
Secondary outcomes (2)
icu stay
duration of stay in the intensive care unit
Measured: 28 days
28 day mortality
mortality by all causes till day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Aug 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karthik T Ponnappan, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462874
- Sponsor's protocol ID
- ILBS - Liver Transplant-4
- Status last verified
- Sep 2021
- First submitted
- 6 Jul 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean Systemic Filling Pressure Trends in Liver Transplant Recipients - a Prospective Observational Pilot Trial
- ClinicalTrials.gov ID
- NCT04462874
- Acronym / sponsor ID
- ILBS - Liver Transplant-4
- Keywords
- liver transplantation, mean systemic filling pressure, advanced hemodynamic monitoring, liver cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with liver diseases undergoing liver transplantation
Key inclusion criteria (1 listed)
- all patients undergoing liver transplantation 18-65 years
Key exclusion criteria (1 listed)
- pregnant patients acute liver failure, acute on chronic liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean systemic filling pressures(MSFP)
Time frame: 1 day
MSFP trends during liver transplantation, hourly
2 secondary outcomes
icu stay
Time frame: 28 days
28 day mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
Related trials for Liver Transplant; Complications
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karthik T Ponnappan principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Liver Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean systemic filling pressures(MSFP) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.