Effect of Rapid Transfusion With Fluid Management System 2000® (FMS)
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Purpose
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 | Intervention |
|---|---|
|
Liver Transplantation |
Device: Fluid management system 2000 (FMS) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (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) |
- 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. ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 10 |
| Study Start Date: | October 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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.
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- liver transplantation recipients
Exclusion Criteria:
- hemoglobin > 10 g/dL before surgery
- renal failure
- hyperkalemia
- chronic hyponatremia
- cardiac dysfunction
Contacts and Locations More Information
No publications provided
| Responsible Party: | Chul-Woo Jung, Assistant Professor, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01448343 History of Changes |
| Other Study ID Numbers: | CWJung_FMS |
| Study First Received: | October 4, 2011 |
| Last Updated: | April 15, 2013 |
| Health Authority: | Korea: Ministry for Health, Welfare and Family Affairs |
Keywords provided by Seoul National University Hospital:
|
transfusion potassium |
ClinicalTrials.gov processed this record on May 21, 2013