Effect of Rapid Transfusion With Fluid Management System 2000® (FMS)

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.

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Key information

Conditions

Liver Transplantation

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-799, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

liver transplantation recipients

Exclusion criteria

hemoglobin > 10 g/dL before surgery
renal failure
hyperkalemia
chronic hyponatremia
cardiac dysfunction

Treatment and study plan

Fluid management system 2000 (FMS)

Device

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.

Primary outcomes

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.

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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Rapid Transfusion With FMS(Fluid Management System 2000®) on the Plasma Potassium Concentration in Adult Liver Transplantation Recipients)

Acronym: FMS

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 7, 2011
Registry last updated: Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed