Aortic Arch Hypoplasia or AtresiaNCT00490256
Modified Perfusion for Neonatal Aortic Arch Reconstruction
A study testing Modified Selective Cerebral Perfusion in people with Aortic Arch Hypoplasia or Atresia, run by Emory University at 1 site in United States.
Trial summary
Even though the lower part of the body does receive some blood supply during Cardiopulmonary Bypass(CPB) surgery, it may not be enough. As a result of this lowered blood supply, there are complications associated with CPB and clamping of the aorta. These include complications with the stomach, intestines and kidneys. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Aortic Arch Hypoplasia or Atresia
- What is being tested?
- Modified Selective Cerebral Perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2010
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis including aortic coarctation, arch hypoplasia, or interrupted aortic arch which requires cardiopulmonary bypass for repair
- age less than 1 year
- parental consent for participation
Who cannot join
- prior aortic arch operations
- emergency operation
- operating surgeon decides that selective cerebral perfusion is not indicated
- Documented renal insufficiency (creatinine > 2.0) or evidence of bowel ischemia prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Evaluation of a Modified Perfusion Strategy for Neonatal Aortic Arch Reconstruction: Does Perfusing the Lower Body During Arch Repair Help?
Even though the lower part of the body does receive some blood supply during Cardiopulmonary Bypass(CPB) surgery, it may not be enough. As a result of this lowered blood supply, there are complications associated with CPB and clamping of the aorta. These include complications with the stomach, intestines and kidneys.
The hypotheses of this study are that increased lower body perfusion during aortic arch reconstruction will decrease intestinal ischemia and the incidence of necrotizing enterocolitis, improve renal function in the postoperative period, and shorten both intensive care unit and hospital length of stay.
The purpose of this research study is to provide the lower part of the body and its organs with possibly more blood supply with a modified form of cardiopulmonary bypass and see if this additional blood supply helps to decrease complications of the kidney, stomach and intestines.
Read the detailed description
As the aorta is repaired, the child has no circulation to the body or brain. While short periods of circulatory arrest were well tolerated, a modified technique called selective cerebral perfusion was developed to maintain blood flow to the brain during aortic repairs so as to allow for less hurried repairs with less concern over brain ischemia and injury.
Selective cerebral perfusion is designed to provide flow to the brain via the right carotid artery and collateral intracranial vessels while the aortic arch is isolated for repair. It is felt that collateral vessels also allow some perfusion of the lower body, but the adequacy of lower body perfusion during selective cerebral perfusion has not been well documented. While it is clear that some blood reaches the lower body, the incidence of renal and gastrointestinal complications following cardiac repairs involving aortic arch reconstructions remains significant.
The goal of this proposal is to evaluate a simple modification of the standard selective cerebral perfusion protocol designed to increase perfusion to the lower body during aortic arch reconstructions. Essentially all children who undergo aortic arch reconstruction at Egleston hospital have either a femoral or umbilical artery catheter in place for routine monitoring. During selective cerebral perfusion, the descending thoracic aorta is clamped, so the lower body arterial line is not a useful monitor at that point. We propose to connect a pressure line from the cardiopulmonary bypass circuit to the lower body arterial catheter, allowing for increased perfusion of the lower body through the femoral/umbilical arterial catheter during selective cerebral perfusion We will monitor simultaneous near infra-red spectroscopy of the brain, flank, and thigh to determine the adequacy of oxygen delivery to the brain, kidney, and lower body musculature during the procedure. Near infra-red spectroscopy provides a measure of the oxygenation of hemoglobin in arterial, capillary, and venous blood within the path of an infra-red sensor. Blood samples will be collected before skin incision, at the end of the procedure, and at 3, 12, and 24 hours after arrival to the intensive care unit. Intestinal fatty acid binding protein (i-FABP) and c-reactive protein (CRP) serum levels will be measured at each timepoint as markers of intestinal ischemia and generalized inflammation respectively. The incidence of documented or suspected necrotizing enterocolitis prior to hospital discharge and the time required to achieve full enteral feeds will be recorded. Renal function will be assayed by the maximal change from preoperative to postoperative serum creatinine, normalized urine output per 12 hour period following surgery, total diuretic dose per day, and daily creatinine clearance for the first 3 days after surgery.
- Conditions
- Aortic Arch Hypoplasia or Atresia
- Being tested
- Modified Selective Cerebral Perfusion
- Keywords
- Selective Cerebral Perfusion, Renal Complications, Gastrointestinal Complications, Aortic Arch Reconstruction, Modified Perfusion, Cardiopulmonary Bypass, Pediatrics, Cardiac Defects, intestinal ischemia, necrotizing entercolitis, Near Infra-red spectroscopy, Creatinine, C-reactive protein levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Selective Cerebral PerfusionProcedure or surgery
Modified Selective perfusion is a cardiopulmonary bypass circuit that has been modified to allow blood flow to the lower body as well as the upper body while the surgery is being performed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit. |
| Experimental | Active comparator | This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit. Receives: Procedure: Modified Selective Cerebral Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Fatty Acid Binding Protein and C-reactive Protein
Measured: Baseline and 0, 3, 12, and 24 hours after surgery
iFAB Post-op
intestinal fatty acid binding protein level immediately postop
Measured: Immediate postop
Secondary outcomes (1)
Cerebral and Lower Body Near Infra-red Spectroscopy Measures
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2010
- Study completionJun 2010
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 (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Arch Hypoplasia or AtresiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Brian Kogon, Emory University
- Investigators
- Paul Kirshbom, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490256
- Sponsor's protocol ID
- IRB00002654
- Status last verified
- May 2014
- First submitted
- 20 Jun 2007
- Last updated
- 3 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jeffries HE, Wells WJ, Starnes VA, Wetzel RC, Moromisato DY. Gastrointestinal morbidity after Norwood palliation for hypoplastic left heart syndrome. Ann Thorac Surg. 2006 Mar;81(3):982-7. doi: 10.1016/j.athoracsur.2005.09.001.
PubMed 16488706Asou T, Kado H, Imoto Y, Shiokawa Y, Tominaga R, Kawachi Y, Yasui H. Selective cerebral perfusion technique during aortic arch repair in neonates. Ann Thorac Surg. 1996 May;61(5):1546-8. doi: 10.1016/0003-4975(96)80002-S.
PubMed 8633985Pigula FA, Siewers RD, Nemoto EM. Regional perfusion of the brain during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 1999 May;117(5):1023-4. doi: 10.1016/S0022-5223(99)70387-9. No abstract available.
PubMed 10220701Pigula FA, Gandhi SK, Siewers RD, Davis PJ, Webber SA, Nemoto EM. Regional low-flow perfusion provides somatic circulatory support during neonatal aortic arch surgery. Ann Thorac Surg. 2001 Aug;72(2):401-6; discussion 406-7. doi: 10.1016/s0003-4975(01)02727-8.
PubMed 11515874
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Modified Perfusion Strategy for Neonatal Aortic Arch Reconstruction: Does Perfusing the Lower Body During Arch Repair Help?
- ClinicalTrials.gov ID
- NCT00490256
- Acronym / sponsor ID
- IRB00002654
- Conditions
- Aortic Arch Hypoplasia or Atresia
- Keywords
- Selective Cerebral Perfusion, Renal Complications, Gastrointestinal Complications, Aortic Arch Reconstruction, Modified Perfusion, Cardiopulmonary Bypass, Pediatrics, Cardiac Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Jun 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Jun 2007 (estimated)
- Results
- Posted 5 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Even though the lower part of the body does receive some blood supply during Cardiopulmonary Bypass(CPB) surgery, it may not be enough. As a result of this lowered blood supply, there are complications associated with CPB and clamping of the aorta. These include complications with the stomach, intestines and kidneys.
The hypotheses of this study are that increased lower body perfusion during aortic arch reconstruction will decrease intestinal ischemia and the incidence of necrotizing enterocolitis, improve renal function in the postoperative period, and shorten both intensive care unit and hospital length of stay.
The purpose of this research study is to provide the lower part of the body and its organs with possibly more blood supply with a modified form of cardiopulmonary bypass and see if this additional blood supply helps to decrease complications of the kidney, stomach and intestines.
Detailed description
As the aorta is repaired, the child has no circulation to the body or brain. While short periods of circulatory arrest were well tolerated, a modified technique called selective cerebral perfusion was developed to maintain blood flow to the brain during aortic repairs so as to allow for less hurried repairs with less concern over brain ischemia and injury.
Selective cerebral perfusion is designed to provide flow to the brain via the right carotid artery and collateral intracranial vessels while the aortic arch is isolated for repair. It is felt that collateral vessels also allow some perfusion of the lower body, but the adequacy of lower body perfusion during selective cerebral perfusion has not been well documented. While it is clear that some blood reaches the lower body, the incidence of renal and gastrointestinal complications following cardiac repairs involving aortic arch reconstructions remains significant.
The goal of this proposal is to evaluate a simple modification of the standard selective cerebral perfusion protocol designed to increase perfusion to the lower body during aortic arch reconstructions. Essentially all children who undergo aortic arch reconstruction at Egleston hospital have either a femoral or umbilical artery catheter in place for routine monitoring. During selective cerebral perfusion, the descending thoracic aorta is clamped, so the lower body arterial line is not a useful monitor at that point. We propose to connect a pressure line from the cardiopulmonary bypass circuit to the lower body arterial catheter, allowing for increased perfusion of the lower body through the femoral/umbilical arterial catheter during selective cerebral perfusion We will monitor simultaneous near infra-red spectroscopy of the brain, flank, and thigh to determine the adequacy of oxygen delivery to the brain, kidney, and lower body musculature during the procedure. Near infra-red spectroscopy provides a measure of the oxygenation of hemoglobin in arterial, capillary, and venous blood within the path of an infra-red sensor. Blood samples will be collected before skin incision, at the end of the procedure, and at 3, 12, and 24 hours after arrival to the intensive care unit. Intestinal fatty acid binding protein (i-FABP) and c-reactive protein (CRP) serum levels will be measured at each timepoint as markers of intestinal ischemia and generalized inflammation respectively. The incidence of documented or suspected necrotizing enterocolitis prior to hospital discharge and the time required to achieve full enteral feeds will be recorded. Renal function will be assayed by the maximal change from preoperative to postoperative serum creatinine, normalized urine output per 12 hour period following surgery, total diuretic dose per day, and daily creatinine clearance for the first 3 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit. |
| Experimental | Active comparator | Procedure: Modified Selective Cerebral PerfusionThis arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis including aortic coarctation, arch hypoplasia, or interrupted aortic arch which requires cardiopulmonary bypass for repair
- age less than 1 year
- parental consent for participation
Key exclusion criteria (4 listed)
- prior aortic arch operations
- emergency operation
- operating surgeon decides that selective cerebral perfusion is not indicated
- Documented renal insufficiency (creatinine > 2.0) or evidence of bowel ischemia prior to surgery
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 |
|---|---|---|
| Modified Selective Cerebral PerfusionModified Selective perfusion is a cardiopulmonary bypass circuit that has been modified to allow blood flow to the lower body as well as the upper body while the surgery is being performed. | Procedure or surgery | Experimental |
Primary outcome
Intestinal Fatty Acid Binding Protein and C-reactive Protein
Time frame: Baseline and 0, 3, 12, and 24 hours after surgery
iFAB Post-op
Time frame: Immediate postop
intestinal fatty acid binding protein level immediately postop
1 secondary outcome
Cerebral and Lower Body Near Infra-red Spectroscopy Measures
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16488706Jeffries HE, Wells WJ, Starnes VA, Wetzel RC, Moromisato DY. Gastrointestinal morbidity after Norwood palliation for hypoplastic left heart syndrome. Ann Thorac Surg. 2006 Mar;81(3):982-7. doi: 10.1016/j.athoracsur.2005.09.001.
- Background: PubMed 8633985Asou T, Kado H, Imoto Y, Shiokawa Y, Tominaga R, Kawachi Y, Yasui H. Selective cerebral perfusion technique during aortic arch repair in neonates. Ann Thorac Surg. 1996 May;61(5):1546-8. doi: 10.1016/0003-4975(96)80002-S.
- Background: PubMed 10220701Pigula FA, Siewers RD, Nemoto EM. Regional perfusion of the brain during neonatal aortic arch reconstruction. J Thorac Cardiovasc Surg. 1999 May;117(5):1023-4. doi: 10.1016/S0022-5223(99)70387-9. No abstract available.
- Background: PubMed 11515874Pigula FA, Gandhi SK, Siewers RD, Davis PJ, Webber SA, Nemoto EM. Regional low-flow perfusion provides somatic circulatory support during neonatal aortic arch surgery. Ann Thorac Surg. 2001 Aug;72(2):401-6; discussion 406-7. doi: 10.1016/s0003-4975(01)02727-8.
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.
Paul Kirshbom, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Selective Cerebral Perfusion in people with Aortic Arch Hypoplasia or Atresia, run by Emory University 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 3 inclusion and 4 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 3 Jun 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 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. 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 5 Aug 2011). 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?
Intestinal Fatty Acid Binding Protein and C-reactive Protein (time frame: Baseline and 0, 3, 12, and 24 hours after surgery). 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 NCT00490256, which also lists 4 linked publications.
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 3 Jun 2014.