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Trial record 27 of 831 for:    Texas Children's Hospital | ( Map: United States )

Nitric Oxide During CPB to Reduce AKI in Neonates

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ClinicalTrials.gov Identifier: NCT03946462
Recruitment Status : Not yet recruiting
First Posted : May 10, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Fabio Savorgnan, Baylor College of Medicine

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 Intervention/treatment Phase
Congenital Heart Disease Acute Kidney Injury Drug: NO gas delivered during cardiac surgery Other: placebo gas delivered during cardiac surgery 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: subjects, caregivers and research team members are blinded while respiratory therapists are unblinded
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 : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.




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)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
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.

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): NCT03946462


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

Locations
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United States, Texas
Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Fabio Savorgnan, MD         
Contact    832-826-6230    fabio.savorgnan@bcm.edu   
Principal Investigator: Fabio Savorgnan, MD         
Sub-Investigator: Lara Shekerdemian, MD         
Sub-Investigator: Paul Checchia, MD         
Sponsors and Collaborators
Fabio Savorgnan
Mallinckrodt
Investigators
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Principal Investigator: Fabio Savorgnan, MD Texas Children's Hospital / Baylor College of Medicine

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Responsible Party: Fabio Savorgnan, Principal Investigator / Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03946462     History of Changes
Other Study ID Numbers: H-44435
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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.: No

Keywords provided by Fabio Savorgnan, Baylor College of Medicine:
Congenital Heart Disease
CHD
Acute Kidney Injury
AKI
Cardiopulmonary bypass
CPB
cardiac surgery
neonate
infant
nitric oxide
NO
gestational age

Additional relevant MeSH terms:
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Heart Diseases
Acute Kidney Injury
Heart Defects, Congenital
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic 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