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NCT Number: NCT01195025

Volume Kinetics for Starch Solution and Acetated Ringers

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.

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Key information

Conditions

Blood Volume Blood Coagulation Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Intensive care unit

Linköping, 581 85, Sweden

About this study

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 (prothrombin complex international normalized ratio), and aPTT (activated partial thromboplastin time) as markers of coagulation. The volunteers are also monitored regarding non-invasive blood pressure and pulse rate.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

healthy males between 20 and 50 years were advertised for. Males due to simplified urine collection during supine position.

Exclusion criteria

under age < 18 years

Treatment and study plan

acetated Ringers

Drug

Infusion of Ringer acetate 20 ml/kg over 30 min

colloid

Drug

Infusion of starch 10 ml/kg over 30 min

Other names: Voluven

colloid+acetated Ringer

Drug

Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.

Other names: Voluven, acetated Ringers

Non-invasive hemoglobin with pulse-oximeter (SpHb)

Device

Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.

Other names: Radical 7, Masimo

Primary outcomes

  1. Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.

    Time frame: 420 minutes

    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.

  2. Elimination Half Life for Different Fluids Alone or When Combined

    Time frame: 420 minutes

    Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.

Secondary outcomes

  1. Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids

    Time frame: 420 min

    Pulse-oximeter based measurements compared with invasive hemoglobin measurements. All paired in the study.

    Accuracy depending on which infusion is selected (Ringer's, Hydroxyethyl starch or a combination of both).

  2. Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)

    Time frame: 30 min

    Difference between true hemoglobin B-Hb and measured hemoglobin with pulseoximeter (SpHb)at the end of an infusion in relation to the initial measured values SpHb and B-Hb at the start of the infusion.

    Relative difference (%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100

  3. Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.

    Time frame: 420 minutes

    The investigators will measure a few markers of coagulation (fibrinogen, thrombocytes, D-Dimer, PK-INR, aPTT, and coagulation factor VII) as well as Cystatin C, serum albumine and hemoglobin 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2010
Registry last updated
Oct 22, 2014

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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