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

Not Applicable

Completed

• Conditions: Liver Transplantation
• Interventions: Device: Fluid management system 2000 (FMS)

• Registration Number: NCT01448343
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• liver transplantation recipients

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Exclusion Criteria

• hemoglobin > 10 g/dL before surgery
• renal failure
• hyperkalemia
• chronic hyponatremia
• cardiac dysfunction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FMS	Fluid management system 2000 (FMS)	Patients who received blood transfusion using FMS

Primary Outcome Measures

Name	Time	Method
Plasma potassium	Transfusion and sampling of blood are made intraoperatively, mainly during the period of hepatectomy. Overall time of data collection is usually within 4 hrs.	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of