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

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ClinicalTrials.gov Identifier: NCT01448343
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : April 16, 2013
Information provided by (Responsible Party):
Chul-Woo Jung, 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.

Condition or disease Intervention/treatment
Liver Transplantation Device: Fluid management system 2000 (FMS)

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Rapid Transfusion With FMS(Fluid Management System 2000®) on the Plasma Potassium Concentration in Adult Liver Transplantation Recipients)
Study Start Date : October 2011
Primary Completion Date : February 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: FMS
Patients who received blood transfusion using FMS
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.

Primary Outcome Measures :
  1. Plasma potassium [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • liver transplantation recipients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448343

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Chul-Woo Jung, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01448343     History of Changes
Other Study ID Numbers: CWJung_FMS
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013

Keywords provided by Chul-Woo Jung, Seoul National University Hospital: