Volume Kinetics for Starch Solution and Acetated Ringers - Full Text View

Purpose

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.

Condition	Intervention
Blood Volume Blood Coagulation	Other: Voluven, acetated Ringers

Study Type:	Interventional
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

Resource links provided by NLM:

Drug Information available for: Hetastarch

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

Blood volume expansion [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
volume kinetics: calculation from hemoglobin variations

Secondary Outcome Measures:

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

Enrollment:	10
Study Start Date:	August 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195025

Locations

Sweden
University Hospital, Intensive care unit
Linköping, Sweden, 581 85

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

Principal Investigator:

Joachim Zdolsek, MD, PhD

University Hospital, Linköping, Sweden

More Information

No publications provided by University Hospital, Linkoeping

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bergek C, Zdolsek JH, Hahn RG. Accuracy of noninvasive haemoglobin measurement by pulse oximetry depends on the type of infusion fluid. Eur J Anaesthesiol. 2013 Feb;30(2):73-9. doi: 10.1097/EJA.0b013e3283592733.

Bergek C, Zdolsek JH, Hahn RG. Accuracy of noninvasive haemoglobin measurement by pulse oximetry depends on the type of infusion fluid. Eur J Anaesthesiol. 2012 Dec;29(12):586-92. doi: 10.1097/EJA.0b013e3283592733.

Responsible Party:	Joachim Zdolsek, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT01195025 History of Changes
Other Study ID Numbers:	VkVR
Study First Received:	August 31, 2010
Last Updated:	May 11, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:

Blood volume
blood coagulation
volume kinetics

ClinicalTrials.gov processed this record on June 18, 2013