NCT06145347

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
629

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

12 months

First QC Date

September 14, 2023

Last Update Submit

August 15, 2024

Conditions

Keywords

NT-proBNPAKIERASabdominal surgery

Outcome Measures

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.

    1 week

Secondary Outcomes (2)

  • AKI grading assessed by KDIGO 2012 (Kidney Disease: Improving Global Outcomes)

    1 week

  • Morbidity

    4 week

Study Arms (2)

Acute kidney injury group

Patients developed acute kidney injury.

Non-Acute kidney injury group

Patients didn't develope acute kidney injury.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with normal renal function undergoing elective abdominal surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

  • 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.

    PMID: 35102042BACKGROUND
  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Hailong Dong

    Xijing Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Head of Anesthesia Clinical Research Center, Xijing Hospital

Study Record Dates

First Submitted

September 14, 2023

First Posted

November 24, 2023

Study Start

July 10, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Locations