Volume Kinetics for Starch Solution and Acetated Ringers

Blood Coagulation Clinical Trial

Official title:

Volume Kinetics for Starch Solution and Acetated Ringers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195025
• Other study ID #: VkVR
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: October 16, 2014
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2014
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation
• Blood Volume

Intervention

Drug:
• acetated Ringers
Infusion of Ringer acetate 20 ml/kg over 30 min
• colloid
Infusion of starch 10 ml/kg over 30 min
• colloid+acetated Ringer
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.

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

Locations

Country	Name	City	State
Sweden	University Hospital, Intensive care unit	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids	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).	420 min	No
Secondary	Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)	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	30 min	No
Secondary	Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.	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.	420 minutes	No