Acute Renal FailureSBIIIvRNCT06926946
SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes
A study testing Intervention Arm- Cerebral Oximetry + Treatment Guideline in people with Acute Renal Failure and Neonatal Morbidity, run by St. John's Research Institute at 1 site in India.
Trial summary
Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Acute Renal Failure, Neonatal Morbidity
- What is being tested?
- Intervention Arm- Cerebral Oximetry + Treatment Guideline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- 31 Jul 2025to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- > 28 weeks of gestation Invasively ventilated
Who cannot join
- major anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
St. jOhn's Medical college & Hospital
Bengaluru, Karnataka, 560034
Saudamini Nesargi, Dr., 919243472262
About this study
Official title: The Effects of Treatment Guided by Cerebral Oximetry Monitoring on Renal Outcomes in Invasively Mechanically Ventilated Neonates: an Ancillary Study of the SafeBoosC-IIIv Trial
Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels.
As low blood pressure is a risk factor for the development of kidney injury, normalizing blood pressure may decrease the incidence of kidney injury in new-borns who are on ventilator.
- Conditions
- Acute Renal Failure, Neonatal Morbidity
- Being tested
- Intervention Arm- Cerebral Oximetry + Treatment Guideline
- Keywords
- Cerebral oximetry, NIRS, Neonate, Ventilated, Kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Arm- Cerebral Oximetry + Treatment GuidelineOther
Also called NIRS
if the cerebral oximeter shows low values, a pre designed treatment guideline will be followed and corrective actions taken.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm- Cerebral Oximetry + Treatment Guideline | Experimental | Neonates who are ventilated in the NICU, in addition to standard care, will be monitored by cerebral oximetry. If the value falls below a certain threshold, the treatment guideline will be followed and corrective interventions undertaken. Receives: Other: Intervention Arm- Cerebral Oximetry + Treatment Guideline |
| Control Arm- standard care | No intervention | Neonates who are ventilated in the NICU will receive standard care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome of death and acute kidney injury
composite outcome of death and acute kidney injury
Measured: From randomization to discharge up to 2months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start31 Jul 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926946
- Sponsor's protocol ID
- 229/2024
- Acronym
- SBIIIvR
- Status last verified
- Jul 2025
- First submitted
- 2 Apr 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Treatment Guided by Cerebral Oximetry Monitoring on Renal Outcomes in Invasively Mechanically Ventilated Neonates: an Ancillary Study of the SafeBoosC-IIIv Trial
- ClinicalTrials.gov ID
- NCT06926946
- Acronym / sponsor ID
- SBIIIvR / 229/2024
- Conditions
- Acute Renal Failure, Neonatal Morbidity
- Keywords
- Cerebral oximetry, NIRS, Neonate, Ventilated, Kidney injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 15 Apr 2025 (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.
Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels.
As low blood pressure is a risk factor for the development of kidney injury, normalizing blood pressure may decrease the incidence of kidney injury in new-borns who are on ventilator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm- Cerebral Oximetry + Treatment Guideline | Experimental | Other: Intervention Arm- Cerebral Oximetry + Treatment GuidelineNeonates who are ventilated in the NICU, in addition to standard care, will be monitored by cerebral oximetry. If the value falls below a certain threshold, the treatment guideline will be followed and corrective interventions undertaken. |
| Control Arm- standard care | No intervention | –Neonates who are ventilated in the NICU will receive standard care only. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- > 28 weeks of gestation Invasively ventilated
Key exclusion criteria (1 listed)
- major anomalies
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 |
|---|---|---|
| Intervention Arm- Cerebral Oximetry + Treatment GuidelineAlso: NIRSif the cerebral oximeter shows low values, a pre designed treatment guideline will be followed and corrective actions taken. | Other | Intervention Arm- Cerebral Oximetry + Treatment Guideline |
Primary outcome
composite outcome of death and acute kidney injury
Time frame: From randomization to discharge up to 2months of life
composite outcome of death and acute kidney injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Renal Failure
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm- Cerebral Oximetry + Treatment Guideline in people with Acute Renal Failure and Neonatal Morbidity, run by St. John's Research Institute at 1 site in India.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Jul 2025. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact saudamini Nesargi, Dr. (9243472262 ext. 91, saudamini_nesargi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcome of death and acute kidney injury (time frame: From randomization to discharge up to 2months of life). 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 23 Jul 2025.