Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Volume Kinetics for Starch Solution and Acetated Ringers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joachim Zdolsek, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01195025
First received: August 31, 2010
Last updated: October 16, 2014
Last verified: October 2014

August 31, 2010
October 16, 2014
August 2010
May 2011   (final data collection date for primary outcome measure)
  • Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both. [ Time Frame: 420 minutes ] [ Designated as safety issue: No ]

    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.

  • Elimination Half Life for Different Fluids Alone or When Combined [ Time Frame: 420 minutes ] [ Designated as safety issue: No ]
    Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.
Blood volume expansion [ Time Frame: 7 h ] [ Designated as safety issue: No ]
volume kinetics: calculation from hemoglobin variations
Complete list of historical versions of study NCT01195025 on ClinicalTrials.gov Archive Site
  • Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids [ Time Frame: 420 min ] [ Designated as safety issue: No ]

    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).

  • Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion) [ Time Frame: 30 min ] [ Designated as safety issue: No ]

    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

  • Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions. [ Time Frame: 420 minutes ] [ 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) 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.
  • Variation of coagulation factors during and after infusion of crystalloid and colloid solutions. [ Time Frame: 7 h ] [ 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 h ] [ Designated as safety issue: No ]
    Pulse-oximeter based measurements compared with invasive
Not Provided
Not Provided
 
Volume Kinetics for Starch Solution and Acetated Ringers
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Blood Volume
  • Blood Coagulation
  • Drug: acetated Ringers
    Infusion of Ringer acetate 20 ml/kg over 30 min
    Other Name: acetated Ringers
  • Drug: colloid
    Infusion of starch 10 ml/kg over 30 min
    Other Name: Voluven
  • Drug: 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.
    Other Names:
    • Voluven
    • acetated Ringers
  • Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
    Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
    Other Name: Radical 7, Masimo
  • A.acetatedRingers, B.colloid & C.colloid+acetatedRingers

    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.

    Interventions:
    • Drug: acetated Ringers
    • Drug: colloid
    • Drug: colloid+acetated Ringer
    • Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
  • A.colloid, B.colloid+acetatedRinger & C.acetatedRingers

    First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.

    Washout >7 days

    Second intervention: B. 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.

    Washout > 7 Days

    Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.

    Interventions:
    • Drug: acetated Ringers
    • Drug: colloid
    • Drug: colloid+acetated Ringer
    • Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
  • A.acetatedRingers, B.acetatedRingers+colloid & C.colloid

    First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 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 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.

    Washout > 7 Days

    Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.

    Interventions:
    • Drug: acetated Ringers
    • Drug: colloid
    • Drug: colloid+acetated Ringer
    • Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
  • A.colloid, B.acetatedRingers & C.colloid+acetatedRingers

    First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.

    Washout >7 days

    Second intervention: B. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.

    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.

    Interventions:
    • Drug: acetated Ringers
    • Drug: colloid
    • Drug: colloid+acetated Ringer
    • Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
  • A.colloid+acetatedRingers, B.colloid & C.acetated Ringers

    First intervention: A. 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.

    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. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.

    Interventions:
    • Drug: acetated Ringers
    • Drug: colloid
    • Drug: colloid+acetated Ringer
    • Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
May 2011
May 2011   (final data collection date for primary outcome measure)

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

Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01195025
VkVR
No
Joachim Zdolsek, University Hospital, Linkoeping
University Hospital, Linkoeping
Not Provided
Principal Investigator: Joachim Zdolsek, MD, PhD University Hospital, Linköping, Sweden
University Hospital, Linkoeping
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP