Volume Kinetics for Starch Solution and Acetated Ringers
NCT ID: NCT01195025
Last Updated: 2014-10-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2010-08-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
NCT07097337
The Effect of Human Albumin on Coagulation Competence and Hemorrhage
NCT02270723
RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
NCT01545635
ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
NCT03674684
Fibrinogen Concentrate In Children After Cardiac Surgery
NCT01187225
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
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.
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.
Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
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.
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.
Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
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.
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.
Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
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.
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.
Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
18 Years
50 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Linkoeping
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joachim Zdolsek
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joachim Zdolsek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Linköping, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital, Intensive care unit
Linköping, Linköping, Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.
Hahn RG, Bergek C, Geback T, Zdolsek J. Interactions between the volume effects of hydroxyethyl starch 130/0.4 and Ringer s acetate. Crit Care. 2013 May 29;17(3):R104. doi: 10.1186/cc12749.
Bergek C, Zdolsek JH, Hahn RG. Accuracy of noninvasive haemoglobin measurement by pulse oximetry depends on the type of infusion fluid. Eur J Anaesthesiol. 2013 Feb;30(2):73-9. doi: 10.1097/EJA.0b013e3283592733.
Bergek C, Zdolsek JH, Hahn RG. Accuracy of noninvasive haemoglobin measurement by pulse oximetry depends on the type of infusion fluid. Eur J Anaesthesiol. 2012 Dec;29(12):586-92. doi: 10.1097/EJA.0b013e3283592733.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VkVR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.