N/A
N=10
Volume Kinetics for Starch Solution and Acetated Ringers
Blood Volume · Blood Coagulation
Bottom Line
View on ClinicalTrials.gov: NCT01195025 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both. — 5.53; 2.94; 3.12; 4 Litre
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- acetated Ringers (Drug); colloid (Drug); colloid+acetated Ringer (Drug); Non-invasive hemoglobin with pulse-oximeter (SpHb) (Device)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University Hospital, Linkoeping
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both. |
5.53; 2.94; 3.12; 4 | — |
| PRIMARY Elimination Half Life for Different Fluids Alone or When Combined |
88; 116; 126; 497 | — |
| SECONDARY Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids |
-5.3; 0.0; 1.5 | — |
| SECONDARY Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion) |
7; -4.3 | — |
| SECONDARY Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions. |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01195025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.