NCT01971333

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

October 23, 2013

Last Update Submit

October 29, 2013

Conditions

Keywords

pulse pressure variationstroke volume variationplethysmographic variation indexfluid responsiveness

Outcome Measures

Primary Outcomes (1)

  • Change of cardiac index after fluid loading

    one day

Secondary Outcomes (3)

  • Fluid responsiveness parameters: pulse pressure variation

    one day

  • Fluid responsiveness parameters: stroke volume variation

    one day

  • Fluid responsiveness parameters: plethysmographic variation index

    one day

Other Outcomes (3)

  • Mean arterial pressure changes

    one day

  • Central venous pressure changes

    one day

  • Heart rate changes

    one day

Study Arms (1)

Liver transplantation

Compare intraoperative change of dynamic parameters after fluid loading: 1. pulse pressure variation 2. stroke volume variation 3. plethysmographic variation index

Eligibility Criteria

Age6 Months - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital

You may qualify if:

  • End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital

You may not qualify if:

  • Allergic reaction
  • preexisting arrythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, NTUH, Taipei, Taiwan

Taipei, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23348202BACKGROUND
  • Wu 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.

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chun Yu Wu, M.D.

    Department of Anesthesiology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations