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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Seoul National University Hospital
Sponsor:
Collaborator:
Seoul National University
Information provided by (Responsible Party):
Chul-Woo Jung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01331889
First received: April 5, 2011
Last updated: November 17, 2014
Last verified: November 2014
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: October 2011
Estimated 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

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331889

Contacts
Contact: Chul-Woo Jung, MD. PhD 82-2-2072-0640 spss@dreamwiz.com
Contact: Ho-Geol Ryu, MD. PhD 82-17-259-9173 hogeol@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chul-Woo Jung, MD. PhD    82-2-2072-2467    spss@snuh.org   
Sub-Investigator: Ho-Geol Ryu, MD. PhD         
Sub-Investigator: Jiwon Lee, MD         
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University
Investigators
Principal Investigator: Chul-Woo Jung, MD. PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Chul-Woo Jung, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01331889     History of Changes
Other Study ID Numbers: FMS_potassium
Study First Received: April 5, 2011
Last Updated: November 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
transfusion
liver transplantation
potassium

ClinicalTrials.gov processed this record on November 23, 2014