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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||subjects, caregivers and research team members are blinded while respiratory therapists are unblinded|
|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|
|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.
- 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)
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
|Contact: Fabio Savorgnan, MDfirstname.lastname@example.org|
|United States, Texas|
|Texas Children's Hospital||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Fabio Savorgnan, MD|
|Contact 832-826-6230 email@example.com|
|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|