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Modified Perfusion for Neonatal Aortic Arch Reconstruction
This study is currently recruiting participants.
Verified by Emory University, July 2008
Sponsors and Collaborators: Emory University
Children's Healthcare of Atlanta
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00490256
  Purpose

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.


Condition Intervention
Aortic Arch Repair
Congenital Heart Defect
Cardiopulmonary Bypass Surgery
Cardiac Surgery
Device: Modified Selective Cerebral Perfusion

MedlinePlus related topics: Congenital Heart Defects
Drug Information available for: Creatinine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Evaluation of a Modified Perfusion Strategy for Neonatal Aortic Arch Reconstruction: Does Perfusing the Lower Body During Arch Repair Help?

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Intraoperative measurement of flank and quadriceps near-infrared spectroscopy [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
  • Intestinal Fatty Acid Binding Protein and C-reactive Protein [ Time Frame: Baseline and 0, 3, 12, and 24 hours after surgery ] [ Designated as safety issue: No ]
  • Creatinine and Blood Urea Nitrogen Levels [ Time Frame: Before and After Surgery ] [ Designated as safety issue: No ]
  • Urine Output and Creatinine Clearance [ Time Frame: Daily for first 3 days after surgery ] [ Designated as safety issue: No ]
  • Incidence of documented or suspected necrotizing enterocolitis [ Time Frame: Prior to hospital discharge ] [ Designated as safety issue: No ]
  • Total Diuretic Dose and Time to reach full enteral feeds [ Time Frame: After surgery until discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
2: Active Comparator
This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
Device: Modified Selective Cerebral Perfusion
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.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490256

Contacts
Contact: Paul Kirshbom, MD 404-785-6310 paul_kirshbom@emoryhealthcare.org

Locations
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Paul Kirshbom, MD     404-785-6310     paul_kirshbom@emoryhealthcare.org    
Principal Investigator: Paul Kirshbom, MD            
Sub-Investigator: Kirk Kanter, MD            
Sub-Investigator: Brian Kogon, MD            
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Paul Kirshbom, MD Emory University
  More Information

Publications:
Responsible Party: Children's Healthcare of Atlanta at Egleston ( Paul Kirshbom, MD )
Study ID Numbers: 00002654
Study First Received: June 20, 2007
Last Updated: July 15, 2008
ClinicalTrials.gov Identifier: NCT00490256  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Emory University:
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

Study placed in the following topic categories:
Heart Diseases
Cardiovascular Abnormalities
Ischemia
Congenital Abnormalities
Heart Defects, Congenital

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009