Heart Defects, CongenitalPhase 2NCT00199771
Hypertonic Saline Dextran in Pediatric Cardiac Surgery
A Phase 2 study testing 7.5% NaCl in 6% dextran 70 solution in people with Heart Defects, Congenital and Transposition of Great Vessels, run by Oslo University Hospital.
Trial summary
The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children. Read more about this study
- Who is it for?
- Ages Up to 16 weeks
- Conditions the study is for
- Heart Defects, Congenital, Transposition of Great Vessels, Heart Septal Defects, Ventricular
- What is being tested?
- 7.5% NaCl in 6% dextran 70 solution
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Feb 2005
- Phase
- Phase 2
- 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 Up to 16 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
- Age below 17 weeks
Who cannot join
- Preoperative: organ failure (other than heart), serum sodium > 155 mmol/l, central venous pressure > 12 mmHg
- Perioperative: core temperature < 25 ºC on CPB, re-heparinization, re-operation
About this study
Official title: The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.
The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.
Read the detailed description
After major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. Inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (CPB). We want to test whether a small infusion of 7.5% NaCl in 6% dextran solution before and after CPB reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (IL-6, IL-8). We also measure extravascular lung water, fluid balance and weight during the first 24 hours post CPB.
- Conditions
- Heart Defects, Congenital, Transposition of Great Vessels, Heart Septal Defects, Ventricular, Endocardial Cushion Defects
- Being tested
- 7.5% NaCl in 6% dextran 70 solution
- Keywords
- Cardiac Surgery, Infant, Infant, Newborn, Hypertonic Solutions, Saline Solution, Hypertonic, Capillary leak, Inflammation Mediators
- Medical subject headings
- Heart Defects, Congenital, Transposition of Great Vessels, Heart Septal Defects, Ventricular, Endocardial Cushion Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.5% NaCl in 6% dextran 70 solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 and IL-8 2 hours post CPB
Extra vascular lung water 2 and 24 hours post CPB
Secondary outcomes (5)
Fluid balance
Weight gain
Cardiac output
Intrathorasic blood volume
Blood pressure during the first 24 hours post CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2004
- Study completionFeb 2005
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BioPhausia
- Investigators
- Gunnar Bentsen, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199771
- Sponsor's protocol ID
- 2003-HSD
- Other IDs
- S-01003 (ethics committee)
- Status last verified
- Jan 2008
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Hypertonic Saline Dextran in Cardiac Surgery Utilizing Cardio Pulmonary Bypass in Children Less Than 17 Weeks Old.
- ClinicalTrials.gov ID
- NCT00199771
- Acronym / sponsor ID
- 2003-HSD
- Conditions
- Heart Defects, Congenital, Transposition of Great Vessels, Heart Septal Defects, Ventricular, Endocardial Cushion Defects
- Keywords
- Cardiac Surgery, Infant, Infant, Newborn, Hypertonic Solutions, Saline Solution, Hypertonic, Capillary leak, Inflammation Mediators
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- BioPhausia
- Study start
- Jun 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to determine whether infusion of hypertonic saline dextran attenuates the inflammatory response and the water overload, during and after major cardiac surgery in small children.
Detailed description
After major cardiac surgery in small children, extravasation of fluid due to increased capillary leak has negative effect on haemodynamics and respiration. Inflammation cascades are activated by surgery and the use of cardio pulmonary bypass (CPB). We want to test whether a small infusion of 7.5% NaCl in 6% dextran solution before and after CPB reduces inflammatory activation by measuring the levels of interleukins 6 and 8 (IL-6, IL-8). We also measure extravascular lung water, fluid balance and weight during the first 24 hours post CPB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 16 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with congenital heart defect undergoing surgery using cardio pulmonary bypass (CPB).
- Age below 17 weeks
Key exclusion criteria (2 listed)
- Preoperative: organ failure (other than heart), serum sodium > 155 mmol/l, central venous pressure > 12 mmHg
- Perioperative: core temperature < 25 ºC on CPB, re-heparinization, re-operation
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 |
|---|---|---|
| 7.5% NaCl in 6% dextran 70 solution | Drug | – |
Primary outcome
IL-6 and IL-8 2 hours post CPB
Extra vascular lung water 2 and 24 hours post CPB
5 secondary outcomes
Fluid balance
Weight gain
Cardiac output
Intrathorasic blood volume
Blood pressure during the first 24 hours post CPB
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 2011.
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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 Bentsen, MD principal investigator
Oslo University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7.5% NaCl in 6% dextran 70 solution in people with Heart Defects, Congenital and Transposition of Great Vessels, run by Oslo University Hospital.
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 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 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
IL-6 and IL-8 2 hours post CPB. 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?
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 2011.