Blood VolumeNCT01195025

Volume Kinetics for Starch Solution and Acetated Ringers

A study testing acetated Ringers, colloid and colloid+acetated Ringer in people with Blood Volume and Blood Coagulation, run by University Hospital, Linkoeping at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Blood Volume, Blood Coagulation
What is being tested?: acetated Ringers, colloid and colloid+acetated Ringer
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteSweden
Study dates: Aug 2010to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

under age < 18 years

Trial locations and contacts

1 site in 1 country.

Sweden1 site

University Hospital, Intensive care unit
Linköping, Linköping, 581 85

Other trials in Sweden

About this study

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.

Read the detailed 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.

Conditions: Blood Volume, Blood Coagulation
Being tested: acetated Ringers, colloid, colloid+acetated Ringer, Non-invasive hemoglobin with pulse-oximeter (SpHb)
Keywords: Blood volume, blood coagulation, volume kinetics
Medical subject headings: Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acetated RingersDrug
Infusion of Ringer acetate 20 ml/kg over 30 min
colloidDrug
Also called Voluven
Infusion of starch 10 ml/kg over 30 min
colloid+acetated RingerDrug
Also called Voluven, acetated Ringers
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)Device
Also called Radical 7, Masimo
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.

Study groups in NCT01195025
Study group	Role	What they receive
A.acetatedRingers, B.colloid & C.colloid+acetatedRingers	Other	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. Receives: Drug: acetated Ringers; Drug: colloid; Drug: colloid+acetated Ringer; Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
A.colloid, B.colloid+acetatedRinger & C.acetatedRingers	Other	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. Receives: Drug: acetated Ringers; Drug: colloid; Drug: colloid+acetated Ringer; Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
A.acetatedRingers, B.acetatedRingers+colloid & C.colloid	Other	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. Receives: Drug: acetated Ringers; Drug: colloid; Drug: colloid+acetated Ringer; Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)
A.colloid, B.acetatedRingers & C.colloid+acetatedRingers	Other	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. Receives: 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	Other	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. Receives: Drug: acetated Ringers; Drug: colloid; Drug: colloid+acetated Ringer; Device: Non-invasive hemoglobin with pulse-oximeter (SpHb)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 420 minutes
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.
Measured: 420 minutes

Secondary outcomes (3)

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).
Measured: 420 min
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
Measured: 30 min
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.
Measured: 420 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010May 2011

First posted3 Sep 2010 (estimated)
Study startAug 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Blood VolumeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01195025
Sponsor's protocol ID: VkVR
Status last verified: Oct 2014
First submitted: 31 Aug 2010
Last updated: 22 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 33957864
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.
PubMed 23718743
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.
PubMed 23303244
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.
PubMed 23047301

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
RecruitingObservational study
Study of New Magnetic Resonance Imaging Methods of the Brain
Healthy Volunteer, Magnetic Resonance Imaging
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Not yet recruitingObservational study
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Subarachnoid Hemorrhage, Aneurysmal

All Blood Volume trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Volume Kinetics for Starch Solution and Acetated Ringers
ClinicalTrials.gov ID: NCT01195025
Acronym / sponsor ID: VkVR
Conditions: Blood Volume, Blood Coagulation
Keywords: Blood volume, blood coagulation, volume kinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University Hospital, LinkoepingUniversity, hospital or other
Study start: Aug 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 3 Sep 2010 (estimated)
Results: Posted 22 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

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

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

under age < 18 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acetated RingersInfusion of Ringer acetate 20 ml/kg over 30 min	Drug	A.acetatedRingers, B.acetatedRingers+colloid & C.colloid, A.acetatedRingers, B.colloid & C.colloid+acetatedRingers, A.colloid+acetatedRingers, B.colloid & C.acetated Ringers, A.colloid, B.acetatedRingers & C.colloid+acetatedRingers, A.colloid, B.colloid+acetatedRinger & C.acetatedRingers
colloidAlso: VoluvenInfusion of starch 10 ml/kg over 30 min	Drug	A.acetatedRingers, B.acetatedRingers+colloid & C.colloid, A.acetatedRingers, B.colloid & C.colloid+acetatedRingers, A.colloid+acetatedRingers, B.colloid & C.acetated Ringers, A.colloid, B.acetatedRingers & C.colloid+acetatedRingers, A.colloid, B.colloid+acetatedRinger & C.acetatedRingers
colloid+acetated RingerAlso: Voluven, acetated RingersInfusion 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.	Drug	A.acetatedRingers, B.acetatedRingers+colloid & C.colloid, A.acetatedRingers, B.colloid & C.colloid+acetatedRingers, A.colloid+acetatedRingers, B.colloid & C.acetated Ringers, A.colloid, B.acetatedRingers & C.colloid+acetatedRingers, A.colloid, B.colloid+acetatedRinger & C.acetatedRingers
Non-invasive hemoglobin with pulse-oximeter (SpHb)Also: Radical 7, MasimoNon-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.	Device	A.acetatedRingers, B.acetatedRingers+colloid & C.colloid, A.acetatedRingers, B.colloid & C.colloid+acetatedRingers, A.colloid+acetatedRingers, B.colloid & C.acetated Ringers, A.colloid, B.acetatedRingers & C.colloid+acetatedRingers, A.colloid, B.colloid+acetatedRinger & C.acetatedRingers

Primary outcome

Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.
Time frame: 420 minutes
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
Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.

3 secondary outcomes

Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids
Time frame: 420 min
Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)
Time frame: 30 min
Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.
Time frame: 420 minutes

Results and safety

Results posted to the registry on 22 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers	2	2
A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers	3	3
A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid	2	2
A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers	2	2
A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers	1	1

Primary outcome: Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.

Time frame: 420 minutes. Median (Inter-Quartile Range). Unit: Litre

Measure	Hydroxyethyl Starch, Ringers and a Combination of Both. n = 10
Distribution volume of Acetated Ringers	5.53 (4.25 to 7.31)
Distribution volume for HES 6%	2.94 (2.65 to 3.31)
Distribution vol for HES combined with Ringer's	3.12 (3.01 to 3.45)
Distribution vol for Ringers combined with HES	4 (3.05 to 4.82)

Population analysed: All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers. Each experiment generated one distribution volume. (In experiment C one for acetated Ringer's and one for Starch (HES 6%)).

Primary outcome: Elimination Half Life for Different Fluids Alone or When Combined

Time frame: 420 minutes. Median (Inter-Quartile Range). Unit: Minutes

Measure	Hydroxyethyl Starch, Ringers and a Combination of Both. n = 10
Elimination half life for Ringer's	88 (54 to 150)
Elimination half life for HES	116 (87 to 152)
Elimination half life for HES (+ Ringer's)	126 (75 to 150)
Elimination half life for Ringer's (+ HES)	497 (146 to 805)

Population analysed: All the 10 participating subjects. Analysis studying the summary of each of the included infusion occasions. Only acetated Ringers, only colloid and finally a combination of colloid and acetated Ringers. Each experiment generated one elimination half-life (In experiment C one for acetated Ringer's and one for starch (HES 6%)).

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Colloid-, Acetated Ringers and Combined	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33957864Hahn 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.
Derived from this study: PubMed 23718743Hahn 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.
Derived from this study: PubMed 23303244Bergek 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.
Derived from this study: PubMed 23047301Bergek 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.

Related trials for Blood Volume

Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
RecruitingObservational study
Study of New Magnetic Resonance Imaging Methods of the Brain
Healthy Volunteer, Magnetic Resonance Imaging
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Active, not recruiting
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Cardiac Surgery
Not yet recruitingObservational study
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Subarachnoid Hemorrhage, Aneurysmal

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joachim Zdolsek, MD, PhD principal investigator

University Hospital, Linköping, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing acetated Ringers, colloid and colloid+acetated Ringer in people with Blood Volume and Blood Coagulation, run by University Hospital, Linkoeping at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both. (time frame: 420 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01195025, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2014.