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Trial record 1 of 1 for:    NCT04216927
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NO During CPB in Neonates to Reduce Risk of AKI

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ClinicalTrials.gov Identifier: NCT04216927
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
Mallinckrodt
Indiana University
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
AKI CHD - Congenital Heart Disease Surgery Drug: Nitric Oxide Drug: Oxygen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: • This pilot study is a single center, double-blind, randomized controlled trial.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nitric Oxide
Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care
Drug: Nitric Oxide
gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit

Placebo Comparator: Oxygen
Standard CPB without NO administered at any point intraoperatively
Drug: Oxygen
Oxygen alone will be entrained for placebo arm




Primary Outcome Measures :
  1. AKI [ Time Frame: 72 hours ]
    Incidence of AKI in the first 72 hours postoperative as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification


Secondary Outcome Measures :
  1. Biomarker evidence of AKI - NGAL [ Time Frame: 72 hours ]
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker neutrophil gelatinase-associated lipocalin (NGAL)

  2. Biomarker evidence of AKI - KIM-1 [ Time Frame: 72 hours ]
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker kidney injury molecule-1 (KIM-1)

  3. Biomarker evidence of AKI - IL-18 [ Time Frame: 72 hours ]
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker interleukin-18 (IL-18)

  4. Biomarker evidence of AKI - L-FABP [ Time Frame: 72 hours ]
    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)

  5. Biomarker evidence of AKI - urinary nitrite [ Time Frame: 72 hours ]
    Incidence of structural AKI in the first 72 hours postoperative will be assessed by measurement of urine biomarker urinary nitrate.

  6. Impact on GFR [ Time Frame: 72 hours ]
    Postoperative GFR measured using serum cystatin C.

  7. Low Cardiac Output [ Time Frame: 48 hours ]
    Incidence of low cardiac output syndrome (LCOS) during the first 48 hours postoperative



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Ages Eligible for Study:   up to 31 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Failure to obtain informed consent from parent/guardian
  2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
  3. Emergency surgery,
  4. Episode of cardiac arrest within 1 week before surgery,
  5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
  6. Use of inhaled NO (iNO) immediately prior to surgery,
  7. Structural renal abnormalities by ultrasound,
  8. Preoperative AKI,
  9. Use of other investigational drugs,
  10. Weight less than <2 kg,
  11. Gestational age <36 weeks,
  12. Major extracardiac congenital anomalies,
  13. Non-English speakers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216927


Contacts
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Contact: David S Cooepr, MD 5138035448 David.Cooper@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: David S. Cooper, MD    513-803-5448    David.Cooper@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Mallinckrodt
Indiana University
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04216927    
Other Study ID Numbers: MOD00004808
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents