Effect of Rapid Transfusion With Fluid Management System 2000® (FMS)

Liver Transplantation Clinical Trial

— FMS  

Official title:

Effect of Rapid Transfusion With FMS(Fluid Management System 2000®) on the Plasma Potassium Concentration in Adult Liver Transplantation Recipients)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448343
• Other study ID #: CWJung_FMS
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: April 15, 2013
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Rapid infusion of red blood cells is known to result in the increase of plasma potassium. The researchers are trying to investigate the change in plasma potassium during rapid infusion of mixed blood components in the reservoir of the fluid management system (FMS) in liver transplant recipients.

Description:

FMS is a standard equipment to prepare for the massive bleeding during the liver transplant surgery. This device usually delivers a mixture of red blood cell (RBC), fresh frozen plasma and normal saline. Rapid infusion of RBC is known to result in the increase of potassium and the decrease of calcium in the plasma of the patient. However there is no report about the consequence of rapid transfusion of the blood mixture in the reservoir of the FMS, especially in the liver transplantation recipients. The primary end point of this study is to investigate the change in the plasma potassium and to assess the possibility of hyperkalemia and related morbidity. Changes of blood pH and plasma calcium will also be sought.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• liver transplantation recipients

Exclusion Criteria:

• hemoglobin > 10 g/dL before surgery

• renal failure

• hyperkalemia

• chronic hyponatremia

• cardiac dysfunction

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• Fluid management system 2000 (FMS)
The FMS has an integrated large volume (about 3000 ml) reservoir and delivers a blood mixture (4 unit RBC, 4 unit FFP and 800 ml normal saline) put in the reservoir at a maximum rate of 750 ml/min.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma potassium	Four units of RBC, four units of FFP and 800 ml of normal saline are put into the FMS reservoir. Samplings of blood are made before, during and after the transfusion of 300 ml of blood mixture. Sites of blood samplings are the infusion line of the FMS and the arterial and central venous lines of the patient. This process is repeated 4 times in a patient. Acquired blood samples are immediately analyzed with a point of care test device (GEM Premier 3000). The result will be analyzed with appropriate statistics such as RMANOVA.	Transfusion and sampling of blood are made intraoperatively, mainly during the period of hepatectomy. Overall time of data collection is usually within 4 hrs.	Yes