- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00490256
Modified Perfusion for Neonatal Aortic Arch Reconstruction
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Arm 1 is the control arm.
This arm will receive the standard cardiopulmonary bypass circuit.
|
|
Active Comparator: Experimental
This arm is the modified selective perfusion arm.
This arm will receive the modified cardiopulmonary circuit.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal Fatty Acid Binding Protein and C-reactive Protein
Time Frame: Baseline and 0, 3, 12, and 24 hours after surgery
|
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
|
Immediate postop
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cerebral and Lower Body Near Infra-red Spectroscopy Measures
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Asou 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.
- Pigula 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.
- Pigula 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00002654
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Arch Hypoplasia or Atresia
-
Al-Azhar UniversityNot yet recruitingMaxillary Hypoplasia | Expansion of Maxillary Arch
-
University Hospital MuensterRecruitingAortic Arch Aneurysm | Aortic Arch | Dissection of Aortic Arch | Triple BranchGermany
-
Queen Fabiola Children's University HospitalUnknownCongenital Hypoplasia of Aortic ArchBelgium
-
Emory UniversityCompletedAortic Arch Replacement | Hemi Arch ReplacementUnited States
-
McGill University Health Centre/Research Institute...MedtronicRecruitingTetralogy of Fallot | Tricuspid Atresia | Single-ventricle | Transposition of Great Vessels | Congenital Heart Defect | Coarctation of Aorta | Atrioventricular Canal | Hypoplastic Left Heart | Interrupted Aortic Arch | Pulmonary Atresia | Aortic AtresiaCanada
-
Fuji Systems CorporationAvaniaActive, not recruitingAortic Aneurysm | Aortic Dissection | Aortic Arch Aneurysm | Aortic Arch; Aneurysm, DissectingGermany, Netherlands
-
Ospedale San DonatoRecruitingAortic Diseases | Aortic Arch | Bovine ArchItaly
-
Hangzhou Endonom Medtech Co., Ltd.Recruiting
-
Hangzhou Endonom Medtech Co., Ltd.Active, not recruiting
-
Endospan Ltd.CompletedAortic Arch AneurysmSwitzerland, Italy, New Zealand
Clinical Trials on Modified Selective Cerebral Perfusion
-
Fuji Systems CorporationAvaniaActive, not recruitingAortic Aneurysm | Aortic Dissection | Aortic Arch Aneurysm | Aortic Arch; Aneurysm, DissectingGermany, Netherlands
-
Tomsk National Research Medical Center of the Russian...CompletedAortic AneurysmRussian Federation
-
Assistance Publique - Hôpitaux de ParisCompletedInfarction, Middle Cerebral Artery | Subarachnoid Haemorrhage | Head Injuries | Intra-cerebral Haemorrhage | Cerebral ThrombosisFrance
-
University of WashingtonNational Institute of Nursing Research (NINR)CompletedTraumatic Brain Injury | Subarachnoid HemorrhageUnited States
-
UMC UtrechtCompletedHypoplastic Left Heart Syndrome | Aortic Coarctation | Congenital Heart DefectsNetherlands
-
National Taiwan University HospitalUnknownOut-Of-Hospital Cardiac ArrestTaiwan
-
Mongi Slim HospitalUnknownTrans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic ShockTunisia
-
University Hospital, BordeauxUniversité Victor Segalen Bordeaux 2Completed
-
University of SarajevoCompletedBrain Injuries | Subarachnoid HemorrhageBosnia and Herzegovina
-
West China HospitalUnknownHypothermia | Circulatory Arrest | Type A Aortic DissectionChina