Blood Volume, ExtravasationNCT01115166

Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation

An observational study of Blood Volume, Extravasation, 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.

Trial summary

In patients undergoing extracorporal circulation during cardiac operation, the hemoglobin is subjected to large changes. The purpose of this study is to see if it is possible with the help of volume kinetic techniques to use these variations to measure blood volume and fluid escape from the intravascular volume. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Blood Volume, Extravasation
How many people: 10 participants
Where: 1 siteSweden
Study dates: May 2010to May 2012
Phase: Observational
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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients subjected to open cardiac surgery, with the help of extracorporal circulation.

Who may be able to join

open heart surgery, with extracorporal circulation
consent to participation

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

University Hospital, Thoracic operation ward
Linköping, Linkoeping, 581 85

Other trials in Sweden

About this study

Read the detailed description

In many clinical situations, such as extensive surgery, it is of value to determine blood volume and rate of fluid loss from the intravascular space, since hypo- and hypervolemia are combined with increased morbidity and mortality. In this study we which to use the large variations in hemoglobin during extracorporal to calculate both these variables.

Hemoglobin is measured every 5 minutes during one hour beginning shortly before start of the heart-lung machine. When the extracorporal circulation begins the hemoglobin decreases due to the quick mix and dilution of the priming fluid from the heart-lung machine with the patients blood.

From the amount of priming fluid and the fall of the hemoglobin, the blood volume can be calculated. If no further fluid is given the next 20 to 30 minutes, the hemoglobin concentration will in most cases increase as a result of the fluid loss from the vascular space. This increase in combination with the diureses can be used to calculate the intravascular fluid loss to the interstitium during surgery.

Sodium concentration will also be measured in parallel with the hemoglobin concentration.

The Sodium concentrations in combination with given and excreted (urine)Sodium can be used in a mass balance to calculate if intracellular edema is induced.

Conditions: Blood Volume, Extravasation
Keywords: blood volume

What participants receive

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

Study groups in NCT01115166
Study group	Role	What they receive
Cardiac surgery		Patients subjected to open cardiac surgery with the help of extracorporal circulation.

What is being measured

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

Blood Volume
volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin.
1. The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation.
2. The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia.
To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated.
Measured: 30 minutes after start of CPB

Secondary outcomes (1)

Intracellular Edema
Mass balance based on repeated Sodium concentration, fluid volume given, given and excreted Sodium.
A positive value indicating intracellular fluid accumulation and a negative value indicating cell dehydration. This is the change that will occur during the first 30 min after start of cardio pulmonary bypass.
Measured: 30 minutes after CPB

Timeline

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

May 2010May 2012

First posted4 May 2010 (estimated)
Study startMay 2010
Primary completionOct 2010
Study completionMay 2012

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 (1)Papers the sponsor has linked to this study.
Other trials for Blood Volume, ExtravasationStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01115166
Sponsor's protocol ID: BVECC
Status last verified: Sep 2012
First submitted: 3 May 2010
Last updated: 8 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tornudd M, Hahn RG, Zdolsek JH. Fluid distribution kinetics during cardiopulmonary bypass. Clinics (Sao Paulo). 2014 Aug;69(8):535-41. doi: 10.6061/clinics/2014(08)06.
PubMed 25141112

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Volume and Fluid Kinetics in Patients Undergoing Extracorporal Circulation
ClinicalTrials.gov ID: NCT01115166
Acronym / sponsor ID: BVECC
Conditions: Blood Volume, Extravasation
Keywords: blood volume
Study type: Observational
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University Hospital, LinkoepingUniversity, hospital or other
Study start: May 2010
Primary completion: Oct 2010 (actual)
Study completion: May 2012 (actual)
First posted: 4 May 2010 (estimated)
Results: Posted 8 Oct 2012

Clinical summary

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

Detailed description

Sodium concentration will also be measured in parallel with the hemoglobin concentration.

The Sodium concentrations in combination with given and excreted (urine)Sodium can be used in a mass balance to calculate if intracellular edema is induced.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cardiac surgery	–	–Patients subjected to open cardiac surgery with the help of extracorporal circulation.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients subjected to open cardiac surgery, with the help of extracorporal circulation.

Key inclusion criteria (2 listed)

open heart surgery, with extracorporal circulation
consent to participation

Key exclusion criteria (0 listed)

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

Primary outcome

Blood Volume
Time frame: 30 minutes after start of CPB
volume kinetic technique: During start of cardio pulmonary by-pass a known amount of fluid will expand the blood volume and dilute the hemoglobin. 1. The hemoglobin variation is used to calculate the blood volume. The last hemoglobin value before CPB and the hemoglobin value directly after start (extrapolated from the following 30 minutes after start) of CPB are used in the calculation. 2. The value for the blood volume directly prior to CPB will be influenced by intra venous fluids given during early stages of the anesthesia. To achieve the blood volume prior to anesthesia a hemoglobin value before anesthesia and the last hemoglobin value before CPB are used to correct the blood volume calculation. In this way blood volume prior to anaesthesia can be calculated.

1 secondary outcome

Intracellular Edema
Time frame: 30 minutes after CPB

Results and safety

Results posted to the registry on 8 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cardiac Surgery	10	10

Primary outcome: Blood Volume

Time frame: 30 minutes after start of CPB. Mean (Standard Deviation). Unit: Litre

Measure	Cardiac Surgery n = 10
Value	4.61 (0.86)

Population analysed: The study was mainly an observational study, and 10 patients was regarded as a sufficient number to register general changes.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients were followed up to 24 hours after CPB. No intervention except additional blood samples was performed, during the CPB.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cardiac Surgery	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): The number of patients was small and it was not possible to use a reference method. Standardization was difficult due to the fact that it was a clinical study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25141112Tornudd M, Hahn RG, Zdolsek JH. Fluid distribution kinetics during cardiopulmonary bypass. Clinics (Sao Paulo). 2014 Aug;69(8):535-41. doi: 10.6061/clinics/2014(08)06.

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?

An observational study of Blood Volume, Extravasation, 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 2 inclusion and 0 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 8 Oct 2012. 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 8 Oct 2012). 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?

Blood Volume (time frame: 30 minutes after start of CPB). 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 NCT01115166, which also lists 1 linked publication.

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 8 Oct 2012.