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CompletedNCT06145347Updated Aug 16, 2024

Correlation Between Preoperative NT-proBNP and Postoperative AKI

An observational study in Acute Kidney Injury, sponsored by Xijing Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-16.

Sponsored by Xijing Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
629
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Kidney Injury

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Keywords

  • NT-proBNP
  • AKI
  • ERAS
  • abdominal surgery
03

In context

Acute Kidney Injury

1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.

This study's enrollment of 629 is above the median of 156 across 795 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with normal renal function undergoing elective abdominal surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
629 participants (actual)
Patient registry
No

Groups and cohorts

  • Acute kidney injury group

    Patients developed acute kidney injury.

  • Non-Acute kidney injury group

    Patients didn't develope acute kidney injury.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 week

Secondary outcomes

  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.

    Time frame: 1 week

  2. Morbidity

    Total postoperative complication

    Time frame: 4 week

07

Study locations

1 site
  • Xijing Hospital
    Xi'an, Shaanxi 710032, China
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in Jul 2024, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2023
First posted
Nov 24, 2023
StartActual
Jul 10, 2023
Primary completionActual
Jul 1, 2024
CompletionActual
Jul 1, 2024
Last update
Aug 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06145347
Lead sponsor
Xijing Hospital
Responsible party
Chong Lei, MD & phD (Principal investigator, Head of Anesthesia Clinical Research Center, Xijing Hospital, Xijing Hospital) — Principal investigator
First posted
Nov 24, 2023
Start date
Jul 10, 2023
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Last update
Aug 16, 2024

Study contacts

Hailong Dong
study chair · Xijing Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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