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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Nitric Oxide During CPB to Reduce AKI in Neonates

Clinicaltrials.gov identifier NCT03946462

Recruitment Status Not yet recruiting

First Posted May 10, 2019

Last update posted September 2, 2020

Study Description

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

  • Condition or Disease:Congenital Heart Disease
    Acute Kidney Injury
  • Intervention/Treatment: Drug: NO gas delivered during cardiac surgery
    Other: placebo gas delivered during cardiac surgery
  • Phase: Phase 1
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 24 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery
  • Estimated Study Start Date: March 2021
  • Estimated Primary Completion Date: March 2022
  • Estimated Study Completion Date: December 2022
Arms and interventions
Arm Intervention/treatment
Experimental: NO Group
Drug: NO 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.
Placebo Comparator: Placebo Group
Other: placebo 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.
Outcome Measures
  • Primary Outcome Measures: 1. NGAL level [ Time Frame: 48 hours ]
    1 of 2 biomarkers to determine acute kidney injury (AKI)
  • 2. Cystatin-C level [ Time Frame: 48 hours ]
    2 of 2 biomarkers to determine acute kidney injury (AKI)
Eligibility Criteria
  • Ages Eligible for Study: up to 30 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts

Contact: Fabio Savorgnan, MD 832-826-6230 fabio.savorgnan@bcm.edu

Locations

United States, Texas
Texas Children's Hospital
Houston

Sponsors and Collaborators

Fabio Savorgnan

Mallinckrodt

Investigators

Principal Investigator: Fabio Savorgnan, MD Texas Children's Hospital / Baylor College of Medicine

More Information
  • Responsible Party: Fabio Savorgnan
  • ClinicalTrials.gov Identifier: NCT03946462 History of Changes
  • Other Study ID Numbers: H-44435
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: September 2, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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
  • Keywords provided by Fabio Savorgnan: Congenital Heart Disease
    Acute Kidney Injury
    cardiac surgery
    neonate
    gestational age
    CPB
    AKI
    NO
    Cardiopulmonary bypass
    infant
    nitric oxide
    CHD
  • Additional relevant MeSH terms: Acute Kidney Injury Heart Diseases