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Trial record 5 of 20 for:    Cystatin | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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 : November 11, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Fabio Savorgnan, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date November 11, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • NGAL level [ Time Frame: 48 hours ]
    1 of 2 biomarkers to determine acute kidney injury (AKI)
  • Cystatin-C level [ Time Frame: 48 hours ]
    2 of 2 biomarkers to determine acute kidney injury (AKI)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03946462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nitric Oxide During CPB to Reduce AKI in Neonates
Official Title  ICMJE A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Congenital Heart Disease
  • Acute Kidney Injury
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: NO Group
    Intervention: Drug: NO gas delivered during cardiac surgery
  • Placebo Comparator: Placebo Group
    Intervention: Other: placebo gas delivered during cardiac surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 30 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fabio Savorgnan, MD 832-826-6230 fabio.savorgnan@bcm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946462
Other Study ID Numbers  ICMJE H-44435
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fabio Savorgnan, Baylor College of Medicine
Study Sponsor  ICMJE Fabio Savorgnan
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Fabio Savorgnan, MD Texas Children's Hospital / Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP