- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331889
Effect of Rapid Transfusion With Fluid Management System (FMS) on Plasma Potassium in Liver Transplantation Recipients
July 6, 2016 updated by: Chul-Woo Jung, Seoul National University Hospital
Potassium Change in the Fluid Management System (FMS) Reservoir and Its Effect on the Plasma Potassium Concentration During Liver Transplantation Surgery
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adult liver transplantation recipients
Description
Inclusion Criteria:
- preoperative anemia (hemoglobin < 10 g/dl)
- preoperative coagulopathy
Exclusion Criteria:
- children under age 18
- low risk of intraoperative bleeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Potassium concentration
plasma potassium concentrations in the Fluid Management System (FMS) reservoir, arterial blood, and central venous blood
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
potassium concentration in the Fluid Management System (FMS) reservoir
Time Frame: after transfusion of 150 ml of blood mixture
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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.
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after transfusion of 150 ml of blood mixture
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plasma potassium of the patient
Time Frame: before and after transfuison of 300 ml of blood mixture
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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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before and after transfuison of 300 ml of blood mixture
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chul-Woo Jung, MD. PhD, Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
April 5, 2011
First Submitted That Met QC Criteria
April 7, 2011
First Posted (Estimate)
April 8, 2011
Study Record Updates
Last Update Posted (Estimate)
July 11, 2016
Last Update Submitted That Met QC Criteria
July 6, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FMS_potassium
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.