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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331889
First Posted: April 8, 2011
Last Update Posted: July 11, 2016
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.
Collaborator:
Seoul National University
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital
  Purpose
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
Condition Requiring Rapid Transfusion During Liver Transplantation Surgery

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chul-Woo Jung, Seoul National University Hospital:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 10
Study Start Date: October 2011
Study Completion Date: April 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Potassium concentration
plasma potassium concentrations in the Fluid Management System (FMS) reservoir, arterial blood, and central venous blood

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • children under age 18
  • low risk of intraoperative bleeding
  Contacts and Locations
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): NCT01331889


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

Responsible Party: Chul-Woo Jung, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01331889     History of Changes
Other Study ID Numbers: FMS_potassium
First Submitted: April 5, 2011
First Posted: April 8, 2011
Last Update Posted: July 11, 2016
Last Verified: July 2016

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