Liver CirrhosisNCT01971333
Dynamic Preload Parameters During Liver Transplantation
An observational study of Liver Cirrhosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). Read more about this study
- Who is it for?
- Ages 6 months to 75 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Oct 2014
- 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 6 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital
Who may be able to join
- End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital
Who cannot join
- Allergic reaction
- preexisting arrythmia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, NTUH, Taipei, Taiwan
Taipei
Chun Yu Wu, M.D., +886-2-23123456 ext. 62158, longersolo@gmail.com
Chun Yu Wu, M.D.
About this study
Official title: The Validity of Dynamic Preload Parameters During Liver Transplantation
The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.
Read the detailed description
Fluid management is crucial during liver transplantation. Patients with cirrhosis and portal hypertension have an altered blood volume distribution and pooling in the splanchnic circulation. Excess administration of intravenous fluid may increase portal hypertension due to splanchnic venous congestion and may also aggravate coagulopathy by dilution. On the other hand, fluid restriction may risk systemic and especially renal hypoperfusion. Traditional static fluid parameter, such as central venous pressure, pulmonary artery occlusion pressure, have been reported inaccurate to predict fluid responsiveness. In comparison, the recent developed dynamic fluid parameters based on heart-lung interaction were reported to be good preload indicators in a variety of different surgical settings. However, the validity of such dynamic fluid parameters is highly dependent on The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.
- Conditions
- Liver Cirrhosis
- Keywords
- pulse pressure variation, stroke volume variation, plethysmographic variation index, fluid responsiveness
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation | Compare intraoperative change of dynamic parameters after fluid loading: 1. pulse pressure variation 2. stroke volume variation 3. plethysmographic variation index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cardiac index after fluid loading
Measured: one day
Secondary outcomes (3)
Fluid responsiveness parameters: pulse pressure variation
Measured: one day
Fluid responsiveness parameters: stroke volume variation
Measured: one day
Fluid responsiveness parameters: plethysmographic variation index
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Yu Wu, M.D., Principal investigator, Department of Anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971333
- Sponsor's protocol ID
- 201309024RIND
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vos JJ, Kalmar AF, Struys MM, Wietasch JK, Hendriks HG, Scheeren TW. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection. Br J Anaesth. 2013 Jun;110(6):940-6. doi: 10.1093/bja/aes508. Epub 2013 Jan 24.
PubMed 23348202Wu CY, Cheng YJ, Liu YJ, Wu TT, Chien CT, Chan KC; NTUH Center of Microcirculation Medical Research (NCMMR). Predicting stroke volume and arterial pressure fluid responsiveness in liver cirrhosis patients using dynamic preload variables: A prospective study of diagnostic accuracy. Eur J Anaesthesiol. 2016 Sep;33(9):645-52. doi: 10.1097/EJA.0000000000000479.
PubMed 27167058
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity of Dynamic Preload Parameters During Liver Transplantation
- ClinicalTrials.gov ID
- NCT01971333
- Acronym / sponsor ID
- 201309024RIND
- Conditions
- Liver Cirrhosis
- Keywords
- pulse pressure variation, stroke volume variation, plethysmographic variation index, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 29 Oct 2013 (estimated)
- 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.
The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.
Detailed description
Fluid management is crucial during liver transplantation. Patients with cirrhosis and portal hypertension have an altered blood volume distribution and pooling in the splanchnic circulation. Excess administration of intravenous fluid may increase portal hypertension due to splanchnic venous congestion and may also aggravate coagulopathy by dilution. On the other hand, fluid restriction may risk systemic and especially renal hypoperfusion. Traditional static fluid parameter, such as central venous pressure, pulmonary artery occlusion pressure, have been reported inaccurate to predict fluid responsiveness. In comparison, the recent developed dynamic fluid parameters based on heart-lung interaction were reported to be good preload indicators in a variety of different surgical settings. However, the validity of such dynamic fluid parameters is highly dependent on The arterial system compliance is compromised in liver cirrhotic patients. Dynamic preload variables are either pressure-based (e.g.pulse pressure variation; PPV), flow-based (e.g. stroke volume variation; SVV), or volume-based (plethysmographic variability index; PVI). It is not yet clear that dynamic preload parameters based on which mechanism will be accurate to predict fluid responsiveness in the cirrhotic patients. Therefore, this study aimed to claried which dynamic preload parameters would be more accurate during the liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation | – | –Compare intraoperative change of dynamic parameters after fluid loading: 1. pulse pressure variation 2. stroke volume variation 3. plethysmographic variation index |
Who may qualify
- Ages
- 6 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital
Key inclusion criteria (1 listed)
- End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital
Key exclusion criteria (2 listed)
- Allergic reaction
- preexisting arrythmia
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
Change of cardiac index after fluid loading
Time frame: one day
3 secondary outcomes
Fluid responsiveness parameters: pulse pressure variation
Time frame: one day
Fluid responsiveness parameters: stroke volume variation
Time frame: one day
Fluid responsiveness parameters: plethysmographic variation index
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Background: PubMed 23348202Vos JJ, Kalmar AF, Struys MM, Wietasch JK, Hendriks HG, Scheeren TW. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection. Br J Anaesth. 2013 Jun;110(6):940-6. doi: 10.1093/bja/aes508. Epub 2013 Jan 24.
- Derived from this study: PubMed 27167058Wu CY, Cheng YJ, Liu YJ, Wu TT, Chien CT, Chan KC; NTUH Center of Microcirculation Medical Research (NCMMR). Predicting stroke volume and arterial pressure fluid responsiveness in liver cirrhosis patients using dynamic preload variables: A prospective study of diagnostic accuracy. Eur J Anaesthesiol. 2016 Sep;33(9):645-52. doi: 10.1097/EJA.0000000000000479.
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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.
Chun Yu Wu, M.D. principal investigator
Department of Anesthesiology, National Taiwan University Hospital
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 Cirrhosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Oct 2013. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun Yu Wu, M.D. (+886-2-23123456 ext. 62158, longersolo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cardiac index after fluid loading (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971333, which also lists 2 linked publications.
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 30 Oct 2013.