Congenital Heart DiseasePhase 1NCT03946462
Nitric Oxide During CPB to Reduce AKI in Neonates
A Phase 1 study testing NO gas delivered during cardiac surgery in people with Congenital Heart Disease and Acute Kidney Injury, run by Fabio Savorgnan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Congenital Heart Disease, Acute Kidney Injury
- What is being tested?
- NO gas delivered during cardiac surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2021to Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery
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
Read the 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.
- Conditions
- Congenital Heart Disease, Acute Kidney Injury
- Being tested
- NO gas delivered during cardiac surgery, placebo gas delivered during cardiac surgery
- Keywords
- Congenital Heart Disease, CHD, Acute Kidney Injury, AKI, Cardiopulmonary bypass, CPB, cardiac surgery, neonate, infant, nitric oxide, NO, gestational age
- Medical subject headings
- Heart Defects, Congenital, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO gas delivered during cardiac surgeryDrug
intra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system.
placebo gas delivered during cardiac surgeryOther
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 group | Role | What they receive |
|---|---|---|
| NO Group | Experimental | Not described Receives: Drug: NO gas delivered during cardiac surgery |
| Placebo Group | Placebo comparator | Not described Receives: Other: placebo gas delivered during cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGAL level
1 of 2 biomarkers to determine acute kidney injury (AKI)
Measured: 48 hours
Cystatin-C level
2 of 2 biomarkers to determine acute kidney injury (AKI)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: This study could not be started because of some technical issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio Savorgnan
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Fabio Savorgnan, Baylor College of Medicine
- Investigators
- Fabio Savorgnan, MD, Principal investigator, Texas Children's Hospital / Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946462
- Sponsor's protocol ID
- H-44435
- Status last verified
- Nov 2021
- First submitted
- 7 May 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Supplemental Nitric Oxide During Cardiopulmonary Bypass to Reduce Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03946462
- Acronym / sponsor ID
- H-44435
- Conditions
- Congenital Heart Disease, Acute Kidney Injury
- Keywords
- Congenital Heart Disease, CHD, Acute Kidney Injury, AKI, Cardiopulmonary bypass, CPB, cardiac surgery, neonate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study could not be started because of some technical issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fabio SavorgnanUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO Group | Experimental | Drug: NO gas delivered during cardiac surgery |
| Placebo Group | Placebo comparator | Other: placebo gas delivered during cardiac surgery |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO gas delivered during cardiac surgeryintra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system. | Drug | NO Group |
| placebo gas delivered during cardiac surgeryplacebo 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. | Other | Placebo Group |
Primary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Savorgnan, MD principal investigator
Texas Children's Hospital / Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NO gas delivered during cardiac surgery in people with Congenital Heart Disease and Acute Kidney Injury, run by Fabio Savorgnan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NGAL level (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.