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Nitric Oxide During CPB to Reduce AKI in Neonates
| 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 |
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 : | 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 : | October 2021 |
| Estimated Primary Completion Date : | October 2022 |
| Estimated Study Completion Date : | March 2023 |
| 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.
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| 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.
|
- 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)
| Ages Eligible for Study: | up to 30 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| Contact: Fabio Savorgnan, MD | 832-826-6230 | fabio.savorgnan@bcm.edu |
| United States, Texas | |
| Texas Children's Hospital | |
| 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 | |
| Principal Investigator: | Fabio Savorgnan, MD | Texas Children's Hospital / Baylor College of Medicine |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||||
| First Posted Date ICMJE | May 10, 2019 | ||||||
| Last Update Posted Date | May 21, 2021 | ||||||
| Estimated Study Start Date ICMJE | October 2021 | ||||||
| Estimated Primary Completion Date | October 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| 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. |
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| 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||
| Estimated Enrollment ICMJE |
24 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | March 2023 | ||||||
| Estimated Primary Completion Date | October 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 30 Days (Child) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| 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 | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Fabio Savorgnan, Baylor College of Medicine | ||||||
| Study Sponsor ICMJE | Fabio Savorgnan | ||||||
| Collaborators ICMJE | Mallinckrodt | ||||||
| Investigators ICMJE |
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| PRS Account | Baylor College of Medicine | ||||||
| Verification Date | May 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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