Volume Kinetics for Starch Solution and Acetated Ringers
Volume kinetics is a method mostly used, so far, to study the distribution and elimination crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement of bleeding during surgery) is poorly studied, though. Also, a recent study showed unexpected volume kinetics for a crystalloid solution when it was given after a colloid solution. The investigators aim to study the volume kinetics of crystalloids and colloids and also the combination of the two in more detail. The investigators will also compare the invasive hemoglobin measurements with measurements from a new non-invasive tool (Radical 7, from Masimo Inc.) which could help to make volume kinetics more practical for everyday use. Finally the investigators will also study the concentrations of a few coagulation factors to see if they can explain the variations in coagulability that has been described in earlier studies of infusion solutions.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Volume Kinetics for Starch Solution and Acetated Ringers|
- Blood volume expansion [ Time Frame: 7 hours ] [ Designated as safety issue: No ]volume kinetics: calculation from hemoglobin variations
- Variation of coagulation factors during and after infusion of crystalloid and colloid solutions. [ Time Frame: 7 hours ] [ Designated as safety issue: No ]The investigators will measure a few markers of coagulation (fibrinogen, thrombocytes, D-Dimer, PK-INR, aPTT, and coagulation factor VII) and how the concentration of these vary with the different dilutions of blood during and after infusion of a colloid and/or a crystalloid solution.
- Non-invasive hemoglobin monitoring [ Time Frame: 7 hours ] [ Designated as safety issue: No ]Pulse-oximeter based measurements compared with invasive
|Study Start Date:||August 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|colloid-, acetated Ringers and combined||
Other: Voluven, acetated Ringers
Infusions at three different occasions separated by at least one week. A. acetated Ringers 25 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes. C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 15 ml/kg bodyweight during 30 minutes.
We will study ten volunteers, each one on three occasions. Each volunteer will receive only crystalloid one time, only colloid another time, and on the third occasion first a colloid and then a crystalloid one hour later. The different protocols will be in random order in the different volunteers. During all these tests we will sample the hemoglobin (both invasive and non-invasive) every fifth minute in the beginning (every tenth minute later) after the infusion. On six to nine occasions during each test we will analyse Albumin, Cystatin-C, Ig-G, Ig-M as markers of hemodilution and D-Dimer, Fibrinogen, Factor VII, PK-INR, and aPTT as markers of coagulation. The volunteers are also monitored regarding non-invasive blood pressure and pulse rate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195025
|University Hospital, Intensive care unit|
|Linköping, Sweden, 581 85|
|Principal Investigator:||Joachim Zdolsek, MD, PhD||University Hospital, Linköping, Sweden|