Heart Defects, CongenitalNCT02306057
Fluid Balance in Children Undergoing Fontan Surgery
An observational study of Heart Defects, Congenital and Hypoplastic Left Heart Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
- What is being tested?
- Pre BCPC, Pre TCPC and BCPC surgery
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2014to Apr 2017
- 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 month to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with congenital heart defect scheduled for Fontan surgery
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein.
The study hypothesis are
- Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
- The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
- Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.
- Being tested
- Pre BCPC, Pre TCPC, BCPC surgery, TCPC
- Medical subject headings
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre BCPCProcedure or surgery
Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
Pre TCPCProcedure or surgery
Routine catheterization before surgical procedure Total CavoPulmonary Connection
BCPC surgeryProcedure or surgery
Surgical procedure Bidirectional CavoPulmonary Connection
TCPCProcedure or surgery
Surgical procedure Total CavoPulmonary Connection
| Study group | Role | What they receive |
|---|---|---|
| Pre BCPC | Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure Receives: Procedure: Pre BCPC | |
| BCPC surgery | Children undergoing surgical BCPC procedure Receives: Procedure: BCPC surgery | |
| Pre TCPC | Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure Receives: Procedure: Pre TCPC | |
| TCPC surgery | Children undergoing surgical TCPC procedure Receives: Procedure: TCPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial colloid osmotic pressure
Change in interstitial colloid osmotic pressure
Measured: Before and after surgery or catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Principal investigator, Marianne Indrebo, Oslo University Hospital
- Investigators
- Marianne Indrebø, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306057
- Sponsor's protocol ID
- 063.09b
- Status last verified
- Apr 2017
- First submitted
- 31 Oct 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Indrebo M, Berg A, Holmstrom H, Seem E, Guthe HJT, Wiig H, Norgard G. Fluid accumulation in the staged Fontan procedure: the impact of colloid osmotic pressures. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):510-517. doi: 10.1093/icvts/ivy298.
PubMed 30371784
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
- ClinicalTrials.gov ID
- NCT02306057
- Acronym / sponsor ID
- 063.09b
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Nov 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Dec 2014 (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.
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein.
The study hypothesis are
- Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
- The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
- Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre BCPC | – | Procedure: Pre BCPCChildren undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure |
| BCPC surgery | – | Procedure: BCPC surgeryChildren undergoing surgical BCPC procedure |
| Pre TCPC | – | Procedure: Pre TCPCChildren undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure |
| TCPC surgery | – | Procedure: TCPCChildren undergoing surgical TCPC procedure |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with congenital heart defect scheduled for Fontan surgery
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Pre BCPCRoutine catheterization before surgical procedure Bidirectional CavoPulmonary Connection | Procedure or surgery | Pre BCPC |
| Pre TCPCRoutine catheterization before surgical procedure Total CavoPulmonary Connection | Procedure or surgery | Pre TCPC |
| BCPC surgerySurgical procedure Bidirectional CavoPulmonary Connection | Procedure or surgery | BCPC surgery |
| TCPCSurgical procedure Total CavoPulmonary Connection | Procedure or surgery | TCPC surgery |
Primary outcome
Interstitial colloid osmotic pressure
Time frame: Before and after surgery or catheterization
Change in interstitial colloid osmotic pressure
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 11 Apr 2017.
- Derived from this study: PubMed 30371784Indrebo M, Berg A, Holmstrom H, Seem E, Guthe HJT, Wiig H, Norgard G. Fluid accumulation in the staged Fontan procedure: the impact of colloid osmotic pressures. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):510-517. doi: 10.1093/icvts/ivy298.
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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.
Marianne Indrebø, MD principal investigator
Oslo 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 and Hypoplastic Left Heart Syndrome, 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 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 11 Apr 2017. 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 and after surgery or catheterization). 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 NCT02306057, 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 11 Apr 2017.