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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
Results First Received: March 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Blood Volume
Blood Coagulation
Interventions: Drug: acetated Ringers
Drug: colloid
Drug: colloid+acetated Ringer
Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10 Healthy male volunteers 18 to 50 years old

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Random crossover study, with at least one week between every study occasion.

Reporting Groups
  Description
A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers

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 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.

A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers

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

A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid

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 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.

A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers

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. 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.

A. Colloid+Acetated Ringers, B.Colloid and 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.


Participant Flow for 3 periods

Period 1:   First Intervention A
    A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers     A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers     A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid     A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers     A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers  
STARTED     2     3     2     2     1  
COMPLETED     2     3     2     2     1  
NOT COMPLETED     0     0     0     0     0  

Period 2:   Second Intervention B
    A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers     A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers     A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid     A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers     A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers  
STARTED     2     3     2     2     1  
COMPLETED     2     3     2     2     1  
NOT COMPLETED     0     0     0     0     0  

Period 3:   Third Intervention C
    A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers     A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers     A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid     A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers     A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers  
STARTED     2     3     2     2     1  
COMPLETED     2     3     2     2     1  
NOT COMPLETED     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dilution Effects of iv Fluids

Three experiments:

A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxy ethyl starch (HES) 6% 10 mL/kg bodyweight during 30 min C. A combination of A and B. HES during 0-30 min and Ringer's during 105-135 minutes.


Baseline Measures
    Dilution Effects of iv Fluids  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  22  ± 3.4  
Gender  
[units: participants]
 
Female     0  
Male     10  
Region of Enrollment  
[units: participants]
 
Sweden     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.   [ Time Frame: 420 minutes ]

2.  Primary:   Elimination Half Life for Different Fluids Alone or When Combined   [ Time Frame: 420 minutes ]

3.  Secondary:   Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids   [ Time Frame: 420 min ]

4.  Secondary:   Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)   [ Time Frame: 30 min ]

5.  Secondary:   Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.   [ Time Frame: 420 minutes ]
Results not yet reported.   Anticipated Reporting Date:   05/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Joachim Zdolsek
Organization: University Hospital Linköping
phone: +46101030000
e-mail: joachim.zdolsek@lio.se


No publications provided by University Hospital, Linkoeping

Publications automatically indexed to this study:

Responsible Party: Joachim Zdolsek, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01195025     History of Changes
Other Study ID Numbers: VkVR
Study First Received: August 31, 2010
Results First Received: March 12, 2014
Last Updated: October 16, 2014
Health Authority: Sweden: Regional Ethical Review Board