Acute Kidney InjuryNCT04954066
Association Between Muscular Tissue Oxygen Saturation and AKI in Older Patients Undergoing Major Abdominal Surgery
An observational study of Acute Kidney Injury, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The aim of this study is to investigate association between muscular oxygen saturation and postoperative acute kidney injury(AKI) in older patients undergoing abdominal surgeries.The investigator also intend to explore the thresholds of muscular oxygen saturation that correlate with a reduced risk of AKI and therefore… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 253 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2021to 1 Aug 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study intend to enroll elder patients having major abdominal surgeries in our center.
Who may be able to join
- Age ≥65 years old,
- ASA scoreⅠ-Ⅲ,
- Scheduled to undergo a 2-hour-or-longer elective major abdominal surgeries
Who cannot join
- Urological surgery or procedure related to renal tissue may be performed during surgeries.
- Nephrectomy or partial nephrectomy was performed before surgeries.
- Preoperative glomerular filtration rate<30ml/1.73m2, or end-stage renal disease or renal transplant.
- Poor hearing or vision and language barrier impeding postoperative assessment.
- Skin condition incompatible with the adhesive oximetry probe.
- Refuse to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
General hospital of Ningxia medical university
Yinchuan, Ningxia, 750004
About this study
Official title: Association Between Muscular Tissue Oxygen Saturation and Postoperative Acute Kidney Injury in Older Patients Undergoing Major Abdominal Surgery: A Prospective Cohort Study
The aim of this study is to investigate association between muscular oxygen saturation and postoperative acute kidney injury(AKI) in older patients undergoing abdominal surgeries.The investigator also intend to explore the thresholds of muscular oxygen saturation that correlate with a reduced risk of AKI and therefore have the potential to be used as therapeutic targets in future.
Read the detailed description
Acute kidney injury is one of the common and serious complications after major abdominal surgeries,which a reported incidence is as high as 7.5-13.4%.The evidence shows that nearly 20% of elder patients with comorbidity are severely related to postoperative AKI,which lead to increased complications, prolonged stays in hospital and higher mortality.What'more,even smaller increases in the levels of serum creatinine (sCr) may predict worse kidney function after 1or 2 years.But there is no effective treatment or strategy for acute kidney injury at the moment.Therefore,early identification and prevention for AKI in perioperative period are key points.
The mechanism of AKI is complex and multifaceted,which includes that surgeries or anesthesia lead to renal hypoperfusion,ischemia and hypoxia. If the anesthesiologists can monitor the oxygenation status of renal tissues and improve it during surgery, it may reduce the incidence of AKI.
Near-infrared spectroscopy (NIRS) is a new noninvasive technique that continuously monitors tissue oxygen saturation by measuring the relative concentrations of oxygenated and deoxygenated hemoglobin within a local tissue area.It has been improved that perioperative muscular oxygen saturation is related to patients outcome.A observational study showed an association between lower intraoperative tissue oxygen saturation monitored on both sides of paraspinal muscle and higher risk of postoperative AKI in patients having cardiac surgery, suggesting a potential similarity of tissue perfusion and oxygenation between renal and muscular tissue beds.
Therefore,in this study, the investigator hypothesizes that monitoring muscular oxygen saturation during period may reflect some part of renal tissue oxygen saturation and associate with postoperative AKI.
- Conditions
- Acute Kidney Injury
- Keywords
- postoperative acute kidney injury, muscular tissue oxygen saturation, Near-infrared spectroscopy
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of AKI in 7 days
Postoperative AKI will be diagnosed according to KDIGO(Kidney Disease Improving Global)as one of the following:
An increase in serum creatinine by≥0.3 mg/dl ( ≥26.5μmol/l) within 48 h; An increase in serum creatinine to ≥1.5 times baseline within the previous 7 days; Urine volume≤0.5 ml/kg/h for 6 h.
Measured: All the patients will be observed in previous 7 days after surgery for AKI.
Secondary outcomes (1)
the incidence of other complications,hospital stays and mortality in 30 days
It includes cardio-cerebrovascular complications,pneumonia,infection,unplanned transfer to ICU,ICU stays and other dysfunction.The severity of complications was categorised as mild,moderate, severe, or fatal using a modified Clavien-Dindo classification.
scheme.
Measured: All the patients will be followed up within 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start11 Sep 2021
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
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.
- 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
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- N xinli, MD, Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954066
- Sponsor's protocol ID
- lingzi-2021-1
- Other IDs
- Yinlingzi
- Status last verified
- Aug 2022
- First submitted
- 29 Jun 2021
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Muscular Tissue Oxygen Saturation and Postoperative Acute Kidney Injury in Older Patients Undergoing Major Abdominal Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04954066
- Acronym / sponsor ID
- lingzi-2021-1
- Conditions
- Acute Kidney Injury
- Keywords
- postoperative acute kidney injury, muscular tissue oxygen saturation, Near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 8 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 association between muscular oxygen saturation and postoperative acute kidney injury(AKI) in older patients undergoing abdominal surgeries.The investigator also intend to explore the thresholds of muscular oxygen saturation that correlate with a reduced risk of AKI and therefore have the potential to be used as therapeutic targets in future.
Detailed description
Acute kidney injury is one of the common and serious complications after major abdominal surgeries,which a reported incidence is as high as 7.5-13.4%.The evidence shows that nearly 20% of elder patients with comorbidity are severely related to postoperative AKI,which lead to increased complications, prolonged stays in hospital and higher mortality.What'more,even smaller increases in the levels of serum creatinine (sCr) may predict worse kidney function after 1or 2 years.But there is no effective treatment or strategy for acute kidney injury at the moment.Therefore,early identification and prevention for AKI in perioperative period are key points.
The mechanism of AKI is complex and multifaceted,which includes that surgeries or anesthesia lead to renal hypoperfusion,ischemia and hypoxia. If the anesthesiologists can monitor the oxygenation status of renal tissues and improve it during surgery, it may reduce the incidence of AKI.
Near-infrared spectroscopy (NIRS) is a new noninvasive technique that continuously monitors tissue oxygen saturation by measuring the relative concentrations of oxygenated and deoxygenated hemoglobin within a local tissue area.It has been improved that perioperative muscular oxygen saturation is related to patients outcome.A observational study showed an association between lower intraoperative tissue oxygen saturation monitored on both sides of paraspinal muscle and higher risk of postoperative AKI in patients having cardiac surgery, suggesting a potential similarity of tissue perfusion and oxygenation between renal and muscular tissue beds.
Therefore,in this study, the investigator hypothesizes that monitoring muscular oxygen saturation during period may reflect some part of renal tissue oxygen saturation and associate with postoperative AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study intend to enroll elder patients having major abdominal surgeries in our center.
Key inclusion criteria (3 listed)
- Age ≥65 years old,
- ASA scoreⅠ-Ⅲ,
- Scheduled to undergo a 2-hour-or-longer elective major abdominal surgeries
Key exclusion criteria (6 listed)
- Urological surgery or procedure related to renal tissue may be performed during surgeries.
- Nephrectomy or partial nephrectomy was performed before surgeries.
- Preoperative glomerular filtration rate<30ml/1.73m2, or end-stage renal disease or renal transplant.
- Poor hearing or vision and language barrier impeding postoperative assessment.
- Skin condition incompatible with the adhesive oximetry probe.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the incidence of AKI in 7 days
Time frame: All the patients will be observed in previous 7 days after surgery for AKI.
Postoperative AKI will be diagnosed according to KDIGO(Kidney Disease Improving Global)as one of the following: An increase in serum creatinine by≥0.3 mg/dl ( ≥26.5μmol/l) within 48 h; An increase in serum creatinine to ≥1.5 times baseline within the previous 7 days; Urine volume≤0.5 ml/kg/h for 6 h.
1 secondary outcome
the incidence of other complications,hospital stays and mortality in 30 days
Time frame: All the patients will be followed up within 30 days after surgery.
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 6 Jul 2023.
- 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.
N xinli, MD study chair
General Hospital of Ningxia Medical University
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 Acute Kidney Injury, run by General Hospital of Ningxia Medical University 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 3 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 6 Jul 2023. 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?
the incidence of AKI in 7 days (time frame: All the patients will be observed in previous 7 days after surgery for AKI.). 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 6 Jul 2023.