NCT06027476

Brief Summary

Acute kidney injury (AKI) is a common complication during the early postoperative period after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and mortality. Identifying preoperative risk factors for postoperative AKI can significantly contribute to the development of preventive strategies and improved perioperative care in this vulnerable patient population. The goal of this retrospective study is to investigate the predictive value of preoperative inflammatory status, as measured by complete blood count-derived inflammatory markers, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), derived neutrophil-to-lymphocyte ratio (dNLR), neutrophil-to-lymphocyte\*platelet ratio (NLPR), systemic immune-inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI), on postoperative AKI in elderly patients undergoing non-cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,472

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 10, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

21 days

First QC Date

August 30, 2023

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with acute kidney injury after surgery

    In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery.

    Within 7 days after surgery

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients (aged ≥ 65 years) who underwent a non-cardiac surgery at Tongji Hospital between July 2018 and December 2021 were included in our study.

You may qualify if:

  • aged ≥ 65 years.
  • general, gynaecological, neurosurgery, orthopaedic, or thoracic surgery.
  • surgery duration lasting longer than one hour.

You may not qualify if:

  • patients with an American Society of Anesthesiologists (ASA) physical status V.
  • those with concurrent cardiac, vascular, transplant or urological surgeries.
  • those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis) or a history of kidney transplantation..
  • those did not have sufficient data required for calculation for inflammatory markers or AKI evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rao Sun

Wuhan, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 7, 2023

Study Start

September 10, 2023

Primary Completion

October 1, 2023

Study Completion

October 5, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations