Acute Kidney Injury, Congenital Heart Disease
Conditions
Keywords
Congenital Heart Disease, CHD, Acute Kidney Injury, AKI, Cardiopulmonary bypass, CPB, cardiac surgery, neonate, infant, nitric oxide, NO, gestational age
Brief summary
This is a prospective, randomized, double-blind, placebo-controlled pilot study to investigate whether supplemental Nitric Oxide (NO) gas delivered during cardiac surgery with cardiopulmonary bypass (CPB) reduces the incidence and impact of acute kidney injury (AKI) in neonates undergoing surgery for congenital heart disease (CHD), when compared to placebo gas
Detailed description
Screening: All patients undergoing either elective or emergency cardiac surgery will be screened against the eligibility criteria. Research Sample Collection: Blood and urine will be collected for the first 48 hours admission and analyzed. The specific time points for these parameters will be: 2 hours, 6 hours, 12 hours 24 hours, and 48 hours post admission. Blood and urine parameters will also be collected as a baseline pre-operative. Patient outcomes will be captured for 30 days post operatively. Research Data Collection: Baseline information will be collected. Other research related variables collected during the surgical intervention and bypass. Additional information will be collected 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after admission as well as outcomes 30 days after the procedure. Participants will be randomly allocated to the NO or control group in a 1:1 ratio. This study is investigating a possible protective role for NO gas administration during bypass on the subsequent development of AKI. NO is typically delivered via large, stand-alone cylinders that are placed at the bedside (or adjacent to the patient) and is set up by respiratory therapists. In this research study, the study gas (NO or placebo) will be delivered directly into the bypass circuit at a constant gas flow. The placebo gas in this study will be 21% (or atmospheric) oxygen, and will appear to all members of the clinical and research teams (with the exception of the respiratory therapist responsible for setting it up) indistinguishable from NO, rendering this a double-blind study for the patient (or caregiver) and the investigators. This minimizes any possibility of bias in the study.
Interventions
DRUGNO gas delivered during cardiac surgery
intra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system.
OTHERplacebo gas delivered during cardiac surgery
placebo blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system. The placebo gas in this study will be 21% (or atmospheric) oxygen.
Sponsors
Mallinckrodt
Fabio Savorgnan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
subjects, caregivers and research team members are blinded while respiratory therapists are unblinded
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No
Inclusion criteria
* Age: \</= 30 days * Gestational age: 38 weeks * Diagnosis: Congenital Heart Disease (CHD) * Planned surgery to include cardiopulmonary bypass (CPB )for underlying CHD * Consent of parent/guardian
Exclusion criteria
* Currently receiving or has received inhaled nitric oxide (NO) or other nitrogen donors such as sildenafil or nitroprusside * Pre-existing acute kidney injury (AKI) as per the AKIN criteria; * Cardiac arrest within one week prior consent; * Prior cardiac surgery with CPB procedure; * Prior history of Extra Corporeal Membrane Oxygenation (ECMO) * Use of another investigational drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NGAL level | 48 hours | 1 of 2 biomarkers to determine acute kidney injury (AKI) |
| Cystatin-C level | 48 hours | 2 of 2 biomarkers to determine acute kidney injury (AKI) |
Countries
United States
Outcome results
None listed