Overview

Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass

Status:
Not yet recruiting

Trial end date:
2022-11-01

Target enrollment:
0

Participant gender:
All

Summary

The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery. GFAP will be analyzed via an enzyme-linked immunosorbent assay (ELISA) kit. Patients will also be monitored post-operatively for delirium in the intensive care unit (ICU). 2. To evaluate the renal protective effect of nitric oxide by measuring neutrophil gelatinase-associated lipocalin (NGAL) before and after surgery. NGAL will also be analyzed via an ELISA kit. Patient creatinine will be monitored post-operatively. 3. To evaluate effect of nitric oxide on other ICU outcomes (invasive mechanical ventilation, days to extubation, ICU and hospital length of stay, and blood product administration).

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Vanderbilt University Medical Center

Treatments:

Nitric Oxide

Criteria

Inclusion Criteria:

1. Neonates and infants with CHD undergoing CPB for corrective surgery

2. Age <1 year old

Exclusion Criteria:

1. Requirement of inhaled NO immediately prior to surgery

2. Emergency surgery

3. Severe developmental delay at baseline defined as a score of ≥ 4 (severe disability)
on the Pediatric Cerebral Performance Category (PCPC) Scale, referencing cognitive
status prior to critical illness

4. Pre-existing renal disease

5. Inability to understand English or deafness that will preclude delirium evaluation.
The inability to understand English in verbal participants will not result in
exclusion when the research staff is proficient and/or translation services are
actively available in that particular language.