RECRUITING

NO During CPB in Neonates to Reduce Risk of AKI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury

Quick Facts

Study Start:2023-01-10
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04216927

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 31 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
  1. 1. Failure to obtain informed consent from parent/guardian
  2. 2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
  3. 3. Emergency surgery,
  4. 4. Episode of cardiac arrest within 1 week before surgery,
  5. 5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
  6. 6. Use of inhaled NO (iNO) immediately prior to surgery,
  7. 7. Structural renal abnormalities by ultrasound,
  8. 8. Preoperative AKI,
  9. 9. Use of other investigational drugs,
  10. 10. Weight less than \<2 kg,
  11. 11. Gestational age \<36 weeks,
  12. 12. Major extracardiac congenital anomalies,
  13. 13. Non-English speakers.

Contacts and Locations

Study Contact

David S Cooepr, MD
CONTACT
5138035448
David.Cooper@cchmc.org

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-10
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2023-01-10
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • AKI
  • CHD - Congenital Heart Disease
  • Surgery