Acute Kidney InjuryNCT06145347
Correlation Between Preoperative NT-proBNP and Postoperative AKI
An observational study of Acute Kidney Injury, run by Xijing Hospital at 1 site in China.
Trial summary
Accurate preoperative AKI risk prediction is of great significance for improving patient outcomes. The use of preoperative NT-proBNP can provide a more precise assessment of the body's fluid load status, guide intraoperative and postoperative fluid management, and thus reduce fluid related postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 629 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 1 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with normal renal function undergoing elective abdominal surgery
Who may be able to join
- ≥18 years
- undergoing elective surgery
- Have a history of NT-proBNP and creatinine testing within 7 days before surgery
Who cannot join
- Patients undergoing chronic peritoneal or hemodialysis treatment; patients who have undergone kidney transplantation; preoperative serum creatinine levels>4.5mg/dL (400 μ Mol/L) or end-stage renal disease patient (defined as glomerular filtration rate<15ml • min-1 • 1.73m-2)
- Organ transplantation surgery
- Pregnant patients
- Surgical duration<1 hour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between the Preoperative N-terminal Pro-B-type Natriuretic Peptide and Acute Kidney Injury After Abdominal Surgery: a Single Center Retrospective Cohort Study Based on ERAS Database
Accurate preoperative AKI risk prediction is of great significance for improving patient outcomes. The use of preoperative NT-proBNP can provide a more precise assessment of the body's fluid load status, guide intraoperative and postoperative fluid management, and thus reduce fluid related postoperative complications. Given the potential association between ERAS and increased postoperative AKI, we hypothesize that preoperative NT-proBNP may be associated with the development of postoperative AKI in ERAS, and can improve the prediction of AKI beyond traditional clinical risk factors. This study aims to validate this hypothesis and provide evidence for using NT-proBNP to assess AKI risk before non cardiac surgery. Improve the predictive ability of clinical predictive models and optimize ERAS protocols to prevent postoperative AKI.
Read the detailed description
Acute kidney injury (AKI) refers to a rapid decrease in glomerular filtration rate. Postoperative AKI refers to AKI that occurs within 7 days after surgery and is one of the serious perioperative complications in surgical patients. The incidence of postoperative AKI reported in different studies ranges from 2% to 39%, with the incidence of AKI after major abdominal surgery reaching as high as 13.4%. Postoperative AKI is associated with poor prognosis of patients, including increased incidence rate of chronic kidney disease, short-term and long-term mortality, prolonged hospitalization and increased medical costs. The data of patients admitted to the intensive care unit after surgery shows that the 10-year survival rate of patients with postoperative AKI is significantly reduced. Early identification of high-risk patients with postoperative AKI is a prerequisite for developing strategies to improve or prevent perioperative kidney injury. In the past decade, preoperative risk prediction models for AKI after non cardiac surgery, such as the SPARK index, have been developed. However, due to the fact that these models mainly rely on medical and medication history, and rarely use objective biomarkers other than glomerular filtration rate, the predictive ability of AKI prediction models currently used in clinical practice is limited.
The occurrence of AKI is related to oxidative stress, cell apoptosis, inflammatory stimulation, and renal ischemia-reperfusion injury caused by insufficient capacity or overload. A randomized clinical trial of 350 people demonstrated that target directed fluid infusion can reduce the occurrence of acute kidney injury. The level of N-terminal B-type natriuretic peptide (NT proBNP) has been proven to accurately reflect the current intravascular fluid balance, without being affected by the hormone axis. Arkom et al. found that NT proBNP can predict the volume load of dialysis patients. In the early stage of pancreatectomy recovery, serum NT proBNP can provide better assessment of intravascular volume compared to BUN/CRN ratio, and BNP levels in patients in the monitoring room are parallel to changes in humoral resuscitation. These data indicate that NT proBNP levels can be used to guide postoperative fluid resuscitation and management.
When myocardial cells are subjected to pressure/stretching stimulation, NT proBNP is produced by the precursor of B-type natriuretic peptide, which is considered to represent the severity of left ventricular dysfunction and can better reflect potential hemodynamic changes and evaluate perioperative risk in surgical patients. NT proBNP is mostly cleared by the kidneys, and recent studies have linked it to the risk of postoperative AKI. Previous studies have reported that the optimal critical value of NT-proBNP in patients with heart failure is influenced by renal dysfunction, and NT-proBNP is significantly elevated in end-stage renal failure patients. It suggests that it may reflect the state of renal function to some extent. The preoperative concentration of NT-proBNP in patients with AKI after non cardiac surgery is significantly higher than that in patients without AKI. In cardiac surgery, an increase in NT-proBNP before surgery is an independent risk factor for postoperative AKI. However, to date, there has been no risk assessment application of NT-proBNP in the non cardiac surgical population.
Postoperative Accelerated Rehabilitation (ERAS) refers to the application of a series of evidence-based and multidisciplinary perioperative optimization measures aimed at reducing the occurrence of complications, promoting rapid recovery of patients, controlling inflammation, reducing stress reactions, and applying evidence-based medicine. Although ERAS brings improvement in patient prognosis, the positive fluid balance caused by ERAS and the use of NSAIDs may lead to damage to renal function. A retrospective study by Patrick S team demonstrated that ERAS is an important risk factor for postoperative AKI. Steven McClane team also found a significant increase in postoperative AKI in colorectal surgery patients who implemented ERAS strategy through propensity score matching.
- Conditions
- Acute Kidney Injury
- Keywords
- NT-proBNP, AKI, ERAS, abdominal surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Acute kidney injury group | Patients developed acute kidney injury. | |
| Non-Acute kidney injury group | Patients didn't develope acute kidney injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI assessed by KDIGO 2012 (Kidney Disease: Improving Global Outcomes)
Postoperative incidence of AKI, serum creatinine increases≥ 0.3mg/dL (≥ 26.5 μ Mol/L) within 48 hours, or the serum creatinine increases to 1.5 times or more of the baseline value within 7 days.
Measured: 1 week
Secondary outcomes (2)
AKI grading assessed by KDIGO 2012 (Kidney Disease: Improving Global Outcomes)
Postoperative AKI grading, KDIGO stage 1 AKI is defined as an increase in serum creatinine of 1.5-1.9 times the baseline value or an increase of ≥ 0.3mg/dL (26.5 μ Mol/L); KDIGO stage 2 AKI: serum creatinine increased to 2-2.9 times the baseline value; KDIGO stage 3 AKI is defined as an increase in blood creatinine to a 3-fold baseline value or 4mg/dL (353.6 μ Mol/L or above, or initiate renal replacement therapy.
Measured: 1 week
Morbidity
Total postoperative complication
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start10 Jul 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
- Investigators
- Hailong Dong, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145347
- Sponsor's protocol ID
- KY-20232265-F-1
- Status last verified
- Aug 2024
- First submitted
- 14 Sep 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ojo B, Campbell CH. Perioperative acute kidney injury: impact and recent update. Curr Opin Anaesthesiol. 2022 Apr 1;35(2):215-223. doi: 10.1097/ACO.0000000000001104.
PubMed 35102042Zhang Z, Zheng Z, Nie H, Dong H, Lei C. Association between the preoperative N-terminal pro-B-type natriuretic peptide and acute kidney injury in gastrointestinal surgery patients managed with enhanced recovery strategy: a retrospective cohort study. Perioper Med (Lond). 2025 Apr 22;14(1):45. doi: 10.1186/s13741-025-00528-6.
PubMed 40264198
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Preoperative N-terminal Pro-B-type Natriuretic Peptide and Acute Kidney Injury After Abdominal Surgery: a Single Center Retrospective Cohort Study Based on ERAS Database
- ClinicalTrials.gov ID
- NCT06145347
- Acronym / sponsor ID
- KY-20232265-F-1
- Conditions
- Acute Kidney Injury
- Keywords
- NT-proBNP, AKI, ERAS, abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 24 Nov 2023 (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.
Accurate preoperative AKI risk prediction is of great significance for improving patient outcomes. The use of preoperative NT-proBNP can provide a more precise assessment of the body's fluid load status, guide intraoperative and postoperative fluid management, and thus reduce fluid related postoperative complications. Given the potential association between ERAS and increased postoperative AKI, we hypothesize that preoperative NT-proBNP may be associated with the development of postoperative AKI in ERAS, and can improve the prediction of AKI beyond traditional clinical risk factors. This study aims to validate this hypothesis and provide evidence for using NT-proBNP to assess AKI risk before non cardiac surgery. Improve the predictive ability of clinical predictive models and optimize ERAS protocols to prevent postoperative AKI.
Detailed description
Acute kidney injury (AKI) refers to a rapid decrease in glomerular filtration rate. Postoperative AKI refers to AKI that occurs within 7 days after surgery and is one of the serious perioperative complications in surgical patients. The incidence of postoperative AKI reported in different studies ranges from 2% to 39%, with the incidence of AKI after major abdominal surgery reaching as high as 13.4%. Postoperative AKI is associated with poor prognosis of patients, including increased incidence rate of chronic kidney disease, short-term and long-term mortality, prolonged hospitalization and increased medical costs. The data of patients admitted to the intensive care unit after surgery shows that the 10-year survival rate of patients with postoperative AKI is significantly reduced. Early identification of high-risk patients with postoperative AKI is a prerequisite for developing strategies to improve or prevent perioperative kidney injury. In the past decade, preoperative risk prediction models for AKI after non cardiac surgery, such as the SPARK index, have been developed. However, due to the fact that these models mainly rely on medical and medication history, and rarely use objective biomarkers other than glomerular filtration rate, the predictive ability of AKI prediction models currently used in clinical practice is limited.
The occurrence of AKI is related to oxidative stress, cell apoptosis, inflammatory stimulation, and renal ischemia-reperfusion injury caused by insufficient capacity or overload. A randomized clinical trial of 350 people demonstrated that target directed fluid infusion can reduce the occurrence of acute kidney injury. The level of N-terminal B-type natriuretic peptide (NT proBNP) has been proven to accurately reflect the current intravascular fluid balance, without being affected by the hormone axis. Arkom et al. found that NT proBNP can predict the volume load of dialysis patients. In the early stage of pancreatectomy recovery, serum NT proBNP can provide better assessment of intravascular volume compared to BUN/CRN ratio, and BNP levels in patients in the monitoring room are parallel to changes in humoral resuscitation. These data indicate that NT proBNP levels can be used to guide postoperative fluid resuscitation and management.
When myocardial cells are subjected to pressure/stretching stimulation, NT proBNP is produced by the precursor of B-type natriuretic peptide, which is considered to represent the severity of left ventricular dysfunction and can better reflect potential hemodynamic changes and evaluate perioperative risk in surgical patients. NT proBNP is mostly cleared by the kidneys, and recent studies have linked it to the risk of postoperative AKI. Previous studies have reported that the optimal critical value of NT-proBNP in patients with heart failure is influenced by renal dysfunction, and NT-proBNP is significantly elevated in end-stage renal failure patients. It suggests that it may reflect the state of renal function to some extent. The preoperative concentration of NT-proBNP in patients with AKI after non cardiac surgery is significantly higher than that in patients without AKI. In cardiac surgery, an increase in NT-proBNP before surgery is an independent risk factor for postoperative AKI. However, to date, there has been no risk assessment application of NT-proBNP in the non cardiac surgical population.
Postoperative Accelerated Rehabilitation (ERAS) refers to the application of a series of evidence-based and multidisciplinary perioperative optimization measures aimed at reducing the occurrence of complications, promoting rapid recovery of patients, controlling inflammation, reducing stress reactions, and applying evidence-based medicine. Although ERAS brings improvement in patient prognosis, the positive fluid balance caused by ERAS and the use of NSAIDs may lead to damage to renal function. A retrospective study by Patrick S team demonstrated that ERAS is an important risk factor for postoperative AKI. Steven McClane team also found a significant increase in postoperative AKI in colorectal surgery patients who implemented ERAS strategy through propensity score matching.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury group | – | –Patients developed acute kidney injury. |
| Non-Acute kidney injury group | – | –Patients didn't develope acute kidney injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with normal renal function undergoing elective abdominal surgery
Key inclusion criteria (3 listed)
- ≥18 years
- undergoing elective surgery
- Have a history of NT-proBNP and creatinine testing within 7 days before surgery
Key exclusion criteria (4 listed)
- Patients undergoing chronic peritoneal or hemodialysis treatment; patients who have undergone kidney transplantation; preoperative serum creatinine levels>4.5mg/dL (400 μ Mol/L) or end-stage renal disease patient (defined as glomerular filtration rate<15ml • min-1 • 1.73m-2)
- Organ transplantation surgery
- Pregnant patients
- Surgical duration<1 hour
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
Incidence of AKI assessed by KDIGO 2012 (Kidney Disease: Improving Global Outcomes)
Time frame: 1 week
Postoperative incidence of AKI, serum creatinine increases≥ 0.3mg/dL (≥ 26.5 μ Mol/L) within 48 hours, or the serum creatinine increases to 1.5 times or more of the baseline value within 7 days.
2 secondary outcomes
AKI grading assessed by KDIGO 2012 (Kidney Disease: Improving Global Outcomes)
Time frame: 1 week
Morbidity
Time frame: 4 week
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 16 Aug 2024.
- Background: PubMed 35102042Ojo B, Campbell CH. Perioperative acute kidney injury: impact and recent update. Curr Opin Anaesthesiol. 2022 Apr 1;35(2):215-223. doi: 10.1097/ACO.0000000000001104.
- Derived from this study: PubMed 40264198Zhang Z, Zheng Z, Nie H, Dong H, Lei C. Association between the preoperative N-terminal pro-B-type natriuretic peptide and acute kidney injury in gastrointestinal surgery patients managed with enhanced recovery strategy: a retrospective cohort study. Perioper Med (Lond). 2025 Apr 22;14(1):45. doi: 10.1186/s13741-025-00528-6.
- 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.
Hailong Dong study chair
Xijing 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 Acute Kidney Injury, run by Xijing 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 3 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: finished, as of the sponsor's last update on 16 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 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?
Incidence of AKI assessed by KDIGO 2012 (Kidney Disease: Improving Global Outcomes) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145347, which also lists 2 linked publications.
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 16 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.