Clinical trial NCT01971333: Dynamic Preload Parameters During Liver Transplantation
Official title: The Validity of Dynamic Preload Parameters During Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Keywords: pulse pressure variation
stroke volume variation
plethysmographic variation index
fluid responsiveness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Allergic reaction
* preexisting arrythmia

Primary outcomes:
measure: Change of cardiac index after fluid loading
timeFrame: one day
Secondary outcomes:
measure: Fluid responsiveness parameters: pulse pressure variation
timeFrame: one day
measure: Fluid responsiveness parameters: stroke volume variation
timeFrame: one day
measure: Fluid responsiveness parameters: plethysmographic variation index
timeFrame: one day
Other outcomes:
measure: Mean arterial pressure changes
timeFrame: one day
measure: Central venous pressure changes
timeFrame: one day
measure: Heart rate changes
timeFrame: one day
Locations:
city: Taipei
country: Taiwan
facility: Department of Anesthesiology, NTUH, Taipei, Taiwan
Study officials:
affiliation: Department of Anesthesiology, National Taiwan University Hospital
name: Chun Yu Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.