Heart Defects, CongenitalNCT01397526
Colloid Osmotic Pressure During Heart Surgery in Children
An observational study of Heart Defects, Congenital, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. The oedema formation is due to increased fluid transport from blood to tissue. This transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. Read more about this study
- Who is it for?
- Ages 1 day to 13 years
- Conditions the study is for
- Heart Defects, Congenital
- How many people
- 9 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Children scheduled for open heart surgery with the use of Cardiopulmonary Bypass at Oslo University Hospital
Who may be able to join
- The diagnosis of a congenital heart defect
- scheduled for open heart surgery with the use of cardiopulmonary bypass
- under 13 year of age
- informed consent obtained from the parents
Who cannot join
- renal failure
- liver failure
Trial locations and contacts
1 site in 1 country.
About this study
Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. The oedema formation is due to increased fluid transport from blood to tissue. This transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary bypass in children. The study hypothesis is that oedema developed during cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage and reduced colloid osmotic pressure gradient through the capillary membrane.
- Conditions
- Heart Defects, Congenital
- Keywords
- Congenital heart disease, Cardiopulmonary bypass, Capillary leak, Colloid osmotic pressure, Children
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial colloid osmotic pressure
Measured: Before, during and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Marianne Indrebo, Oslo University Hospital
- Investigators
- Gunnar Norgard, Prof. PhD, Study chair, Oslo University HospitalAnsgar Berg, Prof. PhD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397526
- Sponsor's protocol ID
- 063.09 (REK)
- Other IDs
- 21443(NSD)
- Status last verified
- Jun 2014
- First submitted
- 18 Jul 2011
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colloid Osmotic Pressure During Heart Surgery in Children
- ClinicalTrials.gov ID
- NCT01397526
- Acronym / sponsor ID
- 063.09 (REK)
- Conditions
- Heart Defects, Congenital
- Keywords
- Congenital heart disease, Cardiopulmonary bypass, Capillary leak, Colloid osmotic pressure, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Jul 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. The oedema formation is due to increased fluid transport from blood to tissue. This transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary bypass in children. The study hypothesis is that oedema developed during cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage and reduced colloid osmotic pressure gradient through the capillary membrane.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children scheduled for open heart surgery with the use of Cardiopulmonary Bypass at Oslo University Hospital
Key inclusion criteria (4 listed)
- The diagnosis of a congenital heart defect
- scheduled for open heart surgery with the use of cardiopulmonary bypass
- under 13 year of age
- informed consent obtained from the parents
Key exclusion criteria (2 listed)
- renal failure
- liver failure
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
Interstitial colloid osmotic pressure
Time frame: Before, during and after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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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.
Gunnar Norgard, Prof. PhD study chair
Oslo University Hospital
Ansgar Berg, Prof. PhD study director
Haukeland University Hospital
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 Heart Defects, Congenital, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 2 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 1 Jul 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interstitial colloid osmotic pressure (time frame: Before, during and after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2014.