Health TrialsbyHealthPanel

NO During CPB in Neonates to Reduce Risk of AKI

ConditionsAKICHD - Congenital Heart DiseaseSurgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-31
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Disqualifiers

Failure to obtain informed consent from parent/guardian

Clinical signs of preoperative persistent elevated pulmonary vascular resistance,

Emergency surgery,

Episode of cardiac arrest within 1 week before surgery,

Trial design

Design model

Sequential

Treatments tested in this trial

  • Nitric Oxide

    Drug

    gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit

  • Oxygen

    Drug

    Oxygen alone will be entrained for placebo arm

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Nitric OxideExperimental treatment 1 intervention
Group B: OxygenPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

AKI

Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification

Time frame
72 hours

Secondary outcomes

1

Biomarker evidence of AKI - NGAL

Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker neutrophil gelatinase-associated lipocalin (NGAL)

Time frame
72 hours
2

Biomarker evidence of AKI - KIM-1

Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker kidney injury molecule-1 (KIM-1)

Time frame
72 hours
3

Biomarker evidence of AKI - IL-18

Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker interleukin-18 (IL-18)

Time frame
72 hours
4

Biomarker evidence of AKI - L-FABP

Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker liver-type fatty acid-binding protein (L-FABP)

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Mallinckrodt

Collaborator

Indiana University

Collaborator

Source ClinicalTrials.gov
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