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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

China1 site
  • Xijing Hospital

    Xi'an, Shaanxi, 710032

Other trials in China

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.

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 groups in NCT06145347
Study groupRoleWhat they receive
Acute kidney injury groupPatients developed acute kidney injury.
Non-Acute kidney injury groupPatients didn't develope acute kidney injury.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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.

  1. First posted24 Nov 2023
  2. Study start10 Jul 2023
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

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)
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 35102042
  • Zhang 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

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.

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