Brief Summary

Volume kinetics is a method mostly used, so far, to study the distribution and elimination of 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

August 1, 2010

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

October 22, 2014

Completed

Last Updated

October 22, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

August 31, 2010

Results QC Date

March 12, 2014

Last Update Submit

October 16, 2014

Conditions

Blood Volume Blood Coagulation

Keywords

Blood volumeblood coagulationvolume kinetics

Outcome Measures

Primary Outcomes (2)

Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.
volume kinetics: mathematical calculation from hemoglobin variations during and after an infusion. Degree of plasma dilution depending on which solution(s) and how much solution is/are given.
420 minutes
Elimination Half Life for Different Fluids Alone or When Combined
Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.
420 minutes

Secondary Outcomes (3)

Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids
420 min
Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)
30 min
Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.
420 minutes

Study Arms (5)

A.acetatedRingers, B.colloid & C.colloid+acetatedRingers

OTHER

First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected. Washout \>7 days Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples. Washout \> 7 Days Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.