Ventricular Septal DefectPhase 2NCT00556361
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
A Phase 2 study testing saline and ketamine in people with Ventricular Septal Defect, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Ventricular Septal Defect
- What is being tested?
- saline and ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Nov 2007
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less than one year of age
- undergoing cardiac surgery for repair of ventricular septal defect
- requiring cardiopulmonary bypass
- not requiring retrogrades cerebral perfusion
Who cannot join
- Downs Syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.
- Conditions
- Ventricular Septal Defect
- Being tested
- saline, ketamine
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
ketamineDrug
2 mg/Kg IV within 5 minutes of cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: saline |
| 2 | Experimental | Not described Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare expression of serum markers of CNS injury
Measured: within 48 hours
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.
Measured: within 48 hours
Secondary outcomes (1)
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJul 2004
- Study completionNov 2007
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 Ventricular Septal DefectStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Adnan T Bhutta, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556361
- Sponsor's protocol ID
- 28781 Bhutta
- Other IDs
- CUMG
- Status last verified
- Nov 2007
- First submitted
- 9 Nov 2007
- Last updated
- 12 Nov 2007
- Results posted
- No
Publications
Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.
PubMed 21926656
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ketamine Prior to Cardiopulmonary Bypass in Children
- ClinicalTrials.gov ID
- NCT00556361
- Acronym / sponsor ID
- 28781 Bhutta
- Conditions
- Ventricular Septal Defect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2004
- Study completion
- Nov 2007 (actual)
- First posted
- 12 Nov 2007 (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.
To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: saline |
| 2 | Experimental | Drug: ketamine |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- less than one year of age
- undergoing cardiac surgery for repair of ventricular septal defect
- requiring cardiopulmonary bypass
- not requiring retrogrades cerebral perfusion
Key exclusion criteria (1 listed)
- Downs Syndrome
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 |
|---|---|---|
| saline2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass | Drug | 1 |
| ketamine2 mg/Kg IV within 5 minutes of cardiopulmonary bypass | Drug | 2 |
Primary outcome
To compare expression of serum markers of CNS injury
Time frame: within 48 hours
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.
Time frame: within 48 hours
1 secondary outcome
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls
Time frame: one month
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 12 Nov 2007.
- Derived from this study: PubMed 21926656Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.
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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.
Adnan T Bhutta, MD principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saline and ketamine in people with Ventricular Septal Defect, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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 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 12 Nov 2007. 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 United States. 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. Some participants in this study may receive a placebo. 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?
To compare expression of serum markers of CNS injury (time frame: within 48 hours). 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 NCT00556361, 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 12 Nov 2007.