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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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00490256
Enrollment
14
Registered
2007-06-22
Start date
2007-06-30
Completion date
2010-06-30
Last updated
2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Arch Hypoplasia or Atresia

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

Brief 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. 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.

Interventions

PROCEDUREModified 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.

Sponsors

Children's Healthcare of Atlanta
CollaboratorOTHER
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intestinal Fatty Acid Binding Protein and C-reactive ProteinBaseline and 0, 3, 12, and 24 hours after surgery
iFAB Post-opImmediate postopintestinal fatty acid binding protein level immediately postop

Secondary

MeasureTime frame
Cerebral and Lower Body Near Infra-red Spectroscopy Measures24 hours

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
7
Experimental
This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
7
Total14

Baseline characteristics

CharacteristicExperimentalControlTotal
Age, Categorical
<=18 years
7 Participants7 Participants14 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous4.7 years
STANDARD_DEVIATION 2.9
9.9 years
STANDARD_DEVIATION 8.5
7.3 years
STANDARD_DEVIATION 6.6
Region of Enrollment
United States
7 participants7 participants14 participants
Sex: Female, Male
Female
5 Participants3 Participants8 Participants
Sex: Female, Male
Male
2 Participants4 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 70 / 7
serious
Total, serious adverse events
0 / 70 / 7

Outcome results

Primary

iFAB Post-op

intestinal fatty acid binding protein level immediately postop

Time frame: Immediate postop

ArmMeasureValue (MEAN)Dispersion
ControliFAB Post-op1590 mcg/mlStandard Deviation 1188
ExperimentaliFAB Post-op564 mcg/mlStandard Deviation 272
Primary

Intestinal Fatty Acid Binding Protein and C-reactive Protein

Time frame: Baseline and 0, 3, 12, and 24 hours after surgery

Secondary

Cerebral and Lower Body Near Infra-red Spectroscopy Measures

Time frame: 24 hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026