Postoperative Acute Kidney InjuryNCT04967105
Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury
An observational study of Postoperative Acute Kidney Injury, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Postoperative Acute Kidney Injury
- What is being tested?
- Near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 157 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2020to 30 Jan 2022
- Phase
- Observational
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 60 years who intend to receive elective hepatectomy surgeries
Who may be able to join
- Elderly patients (defined as 60 years of age or older) scheduled for elective liver resection
Who cannot join
- Emergency surgery
- Liver transplantation
- Preoperative hemodialysis
- BMI > 30
- Renal depth (distance from the capsule of the kidney to the skin surface) > 4 cm
- Unable or failed to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury in Elderly Patients Undergoing Liver Resection: a Prospective Cohort Study
The aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI.
Read the detailed description
Postoperative acute kidney injury (AKI) is a severe complication after liver resection and contributes to increased morbidity and mortality.
Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease. Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.
Despite the multiple risk factors and potential mechanisms that have been identified, the diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for early identification of postoperative AKI. It is of great interest to develop target strategies for close motoring of renal function.
This study is a prospective cohort study to investigate the associations between intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI. Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during the surgical process. The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.
- Conditions
- Postoperative Acute Kidney Injury
- Being tested
- Near-infrared spectroscopy
- Keywords
- liver resection, elderly, renal oxygen saturation, near-infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectroscopyDevice
Before the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis.
| Study group | Role | What they receive |
|---|---|---|
| elderly patients following liver resection | elderly patients (aged ≥60 years) scheduled for any type of liver resection due to benign or malignant hepatobiliary diseases Receives: Device: Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury
Postoperative acute kidney injury is defined according to the KDIGO criterion
Measured: Postoperative 7 days
Secondary outcomes (2)
Death before and 30 days after discharge
Collection of clinical data in the medical record and follow-up update through telephone
Measured: 30 days after discharge
Length of hospital stay
Collection of clinical data in the medical record
Measured: Postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start20 Sep 2020
- Primary completion30 Oct 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 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, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Weidong Mi, PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967105
- Sponsor's protocol ID
- PLAGH-AOC-003
- Status last verified
- Mar 2022
- First submitted
- 12 Jul 2021
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury in Elderly Patients Undergoing Liver Resection: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04967105
- Acronym / sponsor ID
- PLAGH-AOC-003
- Conditions
- Postoperative Acute Kidney Injury
- Keywords
- liver resection, elderly, renal oxygen saturation, near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 19 Jul 2021 (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 aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI.
Detailed description
Postoperative acute kidney injury (AKI) is a severe complication after liver resection and contributes to increased morbidity and mortality.
Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease. Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.
Despite the multiple risk factors and potential mechanisms that have been identified, the diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for early identification of postoperative AKI. It is of great interest to develop target strategies for close motoring of renal function.
This study is a prospective cohort study to investigate the associations between intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI. Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during the surgical process. The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly patients following liver resection | – | Device: Near-infrared spectroscopyelderly patients (aged ≥60 years) scheduled for any type of liver resection due to benign or malignant hepatobiliary diseases |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 60 years who intend to receive elective hepatectomy surgeries
Key inclusion criteria (1 listed)
- Elderly patients (defined as 60 years of age or older) scheduled for elective liver resection
Key exclusion criteria (6 listed)
- Emergency surgery
- Liver transplantation
- Preoperative hemodialysis
- BMI > 30
- Renal depth (distance from the capsule of the kidney to the skin surface) > 4 cm
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 spectroscopyBefore the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis. | Device | elderly patients following liver resection |
Primary outcome
Postoperative acute kidney injury
Time frame: Postoperative 7 days
Postoperative acute kidney injury is defined according to the KDIGO criterion
2 secondary outcomes
Death before and 30 days after discharge
Time frame: 30 days after discharge
Length of hospital stay
Time frame: Postoperative 30 days
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 11 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
Weidong Mi, PhD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative 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 1 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 11 Mar 2022. 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. 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?
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?
Postoperative acute kidney injury (time frame: Postoperative 7 days). 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 11 Mar 2022.