Effect of Rapid Transfusion With Fluid Management System (FMS) on Plasma Potassium in Liver Transplantation Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01331889
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : July 11, 2016
Seoul National University
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 hyperkalemia in the body. However, potassium concentration in the blood mixture (usually made of RBC, FFP and normal saline) in the reservoir of rapid infusion system and its effect on the plasma potassium change during rapid transfusion are unknown. This study is designed to investigate these changes while massive transfusion is performed during liver transplantation surgery.

Condition or disease
Condition Requiring Rapid Transfusion During Liver Transplantation Surgery

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Potassium Change in the Fluid Management System (FMS) Reservoir and Its Effect on the Plasma Potassium Concentration During Liver Transplantation Surgery
Study Start Date : October 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2016

Potassium concentration
plasma potassium concentrations in the Fluid Management System (FMS) reservoir, arterial blood, and central venous blood

Primary Outcome Measures :
  1. potassium concentration in the Fluid Management System (FMS) reservoir [ Time Frame: after transfusion of 150 ml of blood mixture ]
    During bolus transfusion (300ml) of blood mixture, blood sample is taken from the side port of infusion line of Fluid Management System (FMS) when 150 ml of blood mixture was transfused. Because the priming volume of the internal circuit is approximately 100 ml, blood sample that was taken after 150 ml transfusion represents the content in the reservoir.

Secondary Outcome Measures :
  1. plasma potassium of the patient [ Time Frame: before and after transfuison of 300 ml of blood mixture ]
    Just before transfusion starts, blood samples are taken from the central venous catheter and arterial line at the same time to measure baseline values. At the immediate end of transfusion, blood samples are taken again from the same sites to measure the resultant changes.

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult liver transplantation recipients

Inclusion Criteria:

  • preoperative anemia (hemoglobin < 10 g/dl)
  • preoperative coagulopathy

Exclusion Criteria:

  • children under age 18
  • low risk of intraoperative bleeding

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 identifier (NCT number): NCT01331889

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University
Principal Investigator: Chul-Woo Jung, MD. PhD Seoul National University Hospital

Responsible Party: Chul-Woo Jung, Assistant Professor, Seoul National University Hospital Identifier: NCT01331889     History of Changes
Other Study ID Numbers: FMS_potassium
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

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