Clinical trial NCT03946462: Nitric Oxide During CPB to Reduce AKI in Neonates
Official title: A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Congenital Heart Disease
Acute Kidney Injury
Keywords: Congenital Heart Disease
CHD
Acute Kidney Injury
AKI
Cardiopulmonary bypass
CPB
cardiac surgery
neonate
infant
nitric oxide
NO
gestational age
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2019-05-10
Enrollment: 0
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: NGAL level
timeFrame: 48 hours
measure: Cystatin-C level
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Texas Children's Hospital / Baylor College of Medicine
name: Fabio Savorgnan, MD
role: PRINCIPAL_INVESTIGATOR
References: