Dynamic Preload Parameters During Liver Transplantation

Liver Cirrhosis Clinical Trial

Official title:

The Validity of Dynamic Preload Parameters During Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01971333
• Other study ID #: 201309024RIND
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2013
• Last updated: October 29, 2013
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: Chun Yu Wu, M.D.
• Phone: +886-2-23123456
• Email: longersolo[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Allergic reaction

• preexisting arrythmia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cirrhosis

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, NTUH, Taipei, Taiwan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean arterial pressure changes		one day	No
Other	Central venous pressure changes		one day	No
Other	Heart rate changes		one day	No
Primary	Change of cardiac index after fluid loading		one day	No
Secondary	Fluid responsiveness parameters: pulse pressure variation		one day	No
Secondary	Fluid responsiveness parameters: stroke volume variation		one day	No
Secondary	Fluid responsiveness parameters: plethysmographic variation index		one day	No