Dynamic Preload Parameters During Liver Transplantation | NCT01971333

Studies
Dynamic Preload Parameters During Liver Transplantation

NCT01971333

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Oct 30, 2013Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Liver Cirrhosis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Oct 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Oct 23, 2013

First Submission Date that Met QC Criteria

Oct 23, 2013

First Posted Date

Oct 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2013

Last Update Posted Date

Oct 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver transplantation		Compare intraoperative change of dynamic parameters after fluid loading: pulse pressure variation stroke volume variation plethysmographic variation index

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of cardiac index after fluid loading		one day

Secondary Outcomes

Measure	Description	Time Frame
Fluid responsiveness parameters: pulse pressure variation		one day
Fluid responsiveness parameters: stroke volume variation		one day
Fluid responsiveness parameters: plethysmographic variation index

Other Outcomes

Measure	Description	Time Frame
Mean arterial pressure changes		one day
Central venous pressure changes		one day
Heart rate changes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Allergic reaction
preexisting arrythmia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chun Yu Wu, M.D.	Contact	+886-2-23123456	62158	longersolo@gmail.com

Overall Officials

Name	Affiliation	Role
Chun Yu Wu, M.D.	Department of Anesthesiology, National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, NTUH, Taipei, Taiwan	Recruiting	Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23348202	Background	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.
27167058

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes