Single-ventricleNCT06538571
Association of Near Infrared Spectroscopy With Interstage Outcomes
A study testing Near infrared spectroscopy in people with Single-ventricle, run by Advocate Hospital System at 1 site in United States.
Trial summary
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Single-ventricle
- What is being tested?
- Near infrared spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Interventional
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants under 6 months of age
- Infants with single ventricle heart disease and parallel circulation
- Infants who are awaiting the Glenn operation
- Infants who are outpatient
Who cannot join
- Infants over 6 months of age
- Inpatients
- Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
- Infants with ongoing hyperbilirubinemia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Advocate Childrens Hospital
Oak Lawn, Illinois, 60453
Joshua Wong, joshua.wong@aah.org
About this study
Official title: Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.
Read the detailed description
As above
- Conditions
- Single-ventricle
- Being tested
- Near infrared spectroscopy
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared spectroscopyDiagnostic test
Noninvasive monitor for venous saturation
| Study group | Role | What they receive |
|---|---|---|
| NIRS use | Experimental | Patients will have renal near infrared spectroscopy recorded in clinic. Receives: Diagnostic Test: Near infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected admissions
The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period.
Measured: 1 year
Unexpected interventions
The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected need for interventions such as cardiac catheterization interventions or surgical interventions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-ventricleStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advocate Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Wong, Advocate Hospital System
- Investigators
- Joshua Wong, MD, Principal investigator, Advocate Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538571
- Sponsor's protocol ID
- IRB00111841
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Renal Near Infrared Spectroscopy in Outpatients With Parallel Circulation During the Interstage Period and Interstage Morbidity
- ClinicalTrials.gov ID
- NCT06538571
- Acronym / sponsor ID
- IRB00111841
- Conditions
- Single-ventricle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Advocate Hospital SystemUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
The purpose of this study is to assess the utility of renal near infrared spectroscopy in the outpatient setting during the interstage period. The primary aim will be to determine the correlation between oxygen extraction ratio ((arterial pulse oximetry - renal near infrared spectroscopy value)/arterial pulse oximetry value) with need for inpatient admission or intervention. Secondary aims will be to determine the correlation of the oxygen extraction ratio with weight gain, neurodevelopment, unexpected admissions, systemic ventricular strain by echocardiography, and Glenn hospitalization admission characteristics.
Detailed description
As above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRS use | Experimental | Diagnostic Test: Near infrared spectroscopyPatients will have renal near infrared spectroscopy recorded in clinic. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants under 6 months of age
- Infants with single ventricle heart disease and parallel circulation
- Infants who are awaiting the Glenn operation
- Infants who are outpatient
Key exclusion criteria (4 listed)
- Infants over 6 months of age
- Inpatients
- Infants with history of skin injury from the near infrared spectroscopy sensor inpatient
- Infants with ongoing hyperbilirubinemia
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 |
|---|---|---|
| Near infrared spectroscopyNoninvasive monitor for venous saturation | Diagnostic test | NIRS use |
Primary outcome
Unexpected admissions
Time frame: 1 year
The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected admissions during the interstage period.
Unexpected interventions
Time frame: 1 year
The investigators will investigate the correlation between renal near infrared spectroscopy values and unexpected need for interventions such as cardiac catheterization interventions or surgical interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Single-ventricle
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
Active, not recruitingPhase 3
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
RecruitingPhase 1
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
Fontan Circulation
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
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.
Joshua Wong, MD principal investigator
Advocate Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near infrared spectroscopy in people with Single-ventricle, run by Advocate Hospital System 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSHUA WONG, MD (708-684-5580, joshua.wong@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected admissions (time frame: 1 year). 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 7 Aug 2024.