Correlation Between Preoperative NT-proBNP and Postoperative AKI

NCT ID: NCT06145347

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute kidney injury group

Patients developed acute kidney injury.

No interventions assigned to this group

Non-Acute kidney injury group

Patients didn't develope acute kidney injury.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. ≥18 years
2. undergoing elective surgery
3. Have a history of NT-proBNP and creatinine testing within 7 days before surgery

Exclusion Criteria

1. 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)
2. Organ transplantation surgery
3. Pregnant patients
4. Surgical duration\<1 hour
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chong Lei, MD & phD

Principal investigator, Head of Anesthesia Clinical Research Center, Xijing Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hailong Dong

Role: STUDY_CHAIR

Xijing Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35102042 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40264198 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY-20232265-F-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BNP and Vascular Surgery
NCT03926104 UNKNOWN