Volume Kinetics for Starch Solution and Acetated Ringers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joachim Zdolsek, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01195025
First received: August 31, 2010
Last updated: May 11, 2012
Last verified: May 2012

August 31, 2010
May 11, 2012
August 2010
May 2011   (final data collection date for primary outcome measure)
Blood volume expansion [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
volume kinetics: calculation from hemoglobin variations
Blood volume expansion [ Time Frame: 7 h ] [ Designated as safety issue: No ]
volume kinetics: calculation from hemoglobin variations
Complete list of historical versions of study NCT01195025 on ClinicalTrials.gov Archive Site
  • 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
  • Variation of coagulation factors during and after infusion of crystalloid and colloid solutions. [ Time Frame: 7 h ] [ 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 h ] [ Designated as safety issue: No ]
    Pulse-oximeter based measurements compared with invasive
Not Provided
Not Provided
 
Volume Kinetics for Starch Solution and Acetated Ringers
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.

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.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Blood Volume
  • Blood Coagulation
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.
colloid-, acetated Ringers and combined
Intervention: Other: Voluven, acetated Ringers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01195025
VkVR
No
Joachim Zdolsek, University Hospital, Linkoeping
University Hospital, Linkoeping
Not Provided
Principal Investigator: Joachim Zdolsek, MD, PhD University Hospital, Linköping, Sweden
University Hospital, Linkoeping
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP