Acute Kidney InjuryPhase 1ROGARNCT07141693
Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes
A Phase 1 study testing NIRS-guided management and Standard anesthesia management in people with Acute Kidney Injury, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The trial is a prospective, randomized, single-blind, pilot study investigating whether near-infrared spectroscopy (NIRS)-guided optimization of intraoperative renal oxygen saturation reduces postoperative acute kidney injury (AKI) in patients undergoing elective hepatectomy. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- NIRS-guided management and Standard anesthesia management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 24 Apr 2026
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 45 years
- Scheduled for elective hepatectomy
- Planned for general anesthesia with endotracheal intubation
- BMI < 30 kg/m2
- Preoperative ultrasound shows renal cortical to skin distance ≤ 4 cm
- ASA classification I-III
- Consenting to participate and signing informed consent
Who cannot join
- Liver transplantation surgery
- Preoperative renal dysfunction or requirement for dialysis treatment;
- Contraindications to vasoactive drugs such as norepinephrine or dopamine as determined by the clinician;
- Severe cardiopulmonary insufficiency (severe arrhythmia, heart failure, respiratory failure, chronic obstructive pulmonary disease), or a serious cardiovascular or cerebrovascular event within the last six months before randomization (such as acute heart failure, acute myocardial infarction, stroke, etc.);
- Patient refusal to participate or current participation in another experimental study;
- Other factors deemed unsuitable for inclusion by the researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes in Hepatectomy: A Dual-Center, Prospective, Randomized, Single-Blind Investigator-Initiated Pilot Trial
The trial is a prospective, randomized, single-blind, pilot study investigating whether near-infrared spectroscopy (NIRS)-guided optimization of intraoperative renal oxygen saturation reduces postoperative acute kidney injury (AKI) in patients undergoing elective hepatectomy. The trial will enroll 80 adults (≥45 years, American society of Aneshesiologists physical status I-III), randomizing them to either standard anesthesia management or NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ management) is triggered if decreases >10% from baseline. Primary outcomes are the incidence of AKI within 7 days and the 28-day Comprehensive Complication Index (CCI). The study aims to determine if real-time SrtO₂ monitoring and proactive intervention can prevent this serious complication, based on previous observational data linking renal desaturation to AKI risk.
- Conditions
- Acute Kidney Injury
- Being tested
- NIRS-guided management, Standard anesthesia management
- 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.
NIRS-guided managementProcedure or surgery
NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase)
Standard anesthesia managementProcedure or surgery
Standard anesthesia management
| Study group | Role | What they receive |
|---|---|---|
| NIRS-guided anesthesia management group | Experimental | NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase) Receives: Procedure: NIRS-guided management |
| Standard anesthesia management | Placebo comparator | standard anesthesia management Receives: Procedure: Standard anesthesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actue kidney injury
An increase in serum creatinine of ≥26.5 μmol/L from baseline within 48 hours or an increase of ≥50% from baseline within 7 days
Measured: Postoperative Day 1-7
Comprehensive Complication Index
The co-primary outcome is the Comprehensive Complication Index (CCI) score, which includes all complications occurring from randomization to the 28-day follow-up period and calculated using the Clavien-Dindo classification (CDC).
Measured: Postoperative Day 1-28
Secondary outcomes (7)
Total duration and proportion of time during surgery of renal desaturation
Total duration and proportion of time during surgery when renal oxygen saturation decreases by >10% from baseline
Measured: Intraoperative
Area under the curve for renal oxygen desaturation
Area under the curve for renal oxygen saturation decrease by >10% from baseline
Measured: Intraoperative
Use of vasoactive drugs
The type and total dose of vasoactive drugs
Measured: Intraoperative
Intraoperative blood pressure levels
Intraoperative low blood pressure and the lowest level
Measured: Intraoperative
AKI grading
According to serum creatinine level to conduct AKI grade
Measured: Postoperative Day 1-7
Overall incidence of postoperative complications
Overall incidence of postoperative complications, including neurological, respiratory, cardiovascular complications, acute kidney injury, and sepsis.
Measured: Postoperative Day 1-28
mortality
In-hospital mortality and 28-day postoperative mortality
Measured: Postoperative Day 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Feb 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Responsible party
- Principal investigator, Hao Li, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141693
- Sponsor's protocol ID
- ChinesePLA_ROGAR_Pilot
- Acronym
- ROGAR
- Status last verified
- May 2026
- First submitted
- 9 Aug 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes in Hepatectomy: A Dual-Center, Prospective, Randomized, Single-Blind Investigator-Initiated Pilot Trial
- ClinicalTrials.gov ID
- NCT07141693
- Acronym / sponsor ID
- ROGAR / ChinesePLA_ROGAR_Pilot
- Conditions
- Acute Kidney Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 26 Aug 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.
The trial is a prospective, randomized, single-blind, pilot study investigating whether near-infrared spectroscopy (NIRS)-guided optimization of intraoperative renal oxygen saturation reduces postoperative acute kidney injury (AKI) in patients undergoing elective hepatectomy. The trial will enroll 80 adults (≥45 years, American society of Aneshesiologists physical status I-III), randomizing them to either standard anesthesia management or NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ management) is triggered if decreases >10% from baseline. Primary outcomes are the incidence of AKI within 7 days and the 28-day Comprehensive Complication Index (CCI). The study aims to determine if real-time SrtO₂ monitoring and proactive intervention can prevent this serious complication, based on previous observational data linking renal desaturation to AKI risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIRS-guided anesthesia management group | Experimental | Procedure: NIRS-guided managementNIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase) |
| Standard anesthesia management | Placebo comparator | Procedure: Standard anesthesia managementstandard anesthesia management |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 45 years
- Scheduled for elective hepatectomy
- Planned for general anesthesia with endotracheal intubation
- BMI < 30 kg/m2
- Preoperative ultrasound shows renal cortical to skin distance ≤ 4 cm
Key exclusion criteria (6 listed)
- Liver transplantation surgery
- Preoperative renal dysfunction or requirement for dialysis treatment;
- Contraindications to vasoactive drugs such as norepinephrine or dopamine as determined by the clinician;
- Severe cardiopulmonary insufficiency (severe arrhythmia, heart failure, respiratory failure, chronic obstructive pulmonary disease), or a serious cardiovascular or cerebrovascular event within the last six months before randomization (such as acute heart failure, acute myocardial infarction, stroke, etc.);
- Patient refusal to participate or current participation in another experimental study;
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 |
|---|---|---|
| NIRS-guided managementNIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase) | Procedure or surgery | NIRS-guided anesthesia management group |
| Standard anesthesia managementStandard anesthesia management | Procedure or surgery | Standard anesthesia management |
Primary outcome
Actue kidney injury
Time frame: Postoperative Day 1-7
An increase in serum creatinine of ≥26.5 μmol/L from baseline within 48 hours or an increase of ≥50% from baseline within 7 days
Comprehensive Complication Index
Time frame: Postoperative Day 1-28
The co-primary outcome is the Comprehensive Complication Index (CCI) score, which includes all complications occurring from randomization to the 28-day follow-up period and calculated using the Clavien-Dindo classification (CDC).
7 secondary outcomes
Total duration and proportion of time during surgery of renal desaturation
Time frame: Intraoperative
Area under the curve for renal oxygen desaturation
Time frame: Intraoperative
Use of vasoactive drugs
Time frame: Intraoperative
Intraoperative blood pressure levels
Time frame: Intraoperative
AKI grading
Time frame: Postoperative Day 1-7
Overall incidence of postoperative complications
Time frame: Postoperative Day 1-28
mortality
Time frame: Postoperative Day 1-28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NIRS-guided management and Standard anesthesia management in people with Acute Kidney Injury, run by Chinese PLA General Hospital at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 8 May 2026. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Actue kidney injury (time frame: Postoperative Day 1-7). 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 8 May 2026.