NCT05945940

Brief Summary

There is a high prevalence of postoperative acute kidney injury (AKI) in patients who undergo intra-abdominal surgery, and it is particularly common in the elderly. Identifying high-risk patients for postoperative AKI early can facilitate the development of preventive and therapeutic management strategies. The goal of this retrospective study is to investigate the predictive value of preoperative nutritional status, as measured by three scoring systems - the geriatric nutritional risk index (GNRI), prognostic nutritional index (PNI), and controlling nutritional status (CONUT) score - on postoperative AKI in elderly patients undergoing major abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,977

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

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

July 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

10 days

First QC Date

July 7, 2023

Last Update Submit

October 5, 2023

Conditions

Postoperative Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Postoperative acute kidney injury

    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

Interventions

no interventionOTHER

no intervention

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 major abdominal surgery under general anesthesia at Tongji Hospital between July 2018 and December 2021 were included in our study.

You may qualify if:

  • aged ≥ 65 years
  • intra-abdominal procedures including gastric, colorectal, pancreatic, prostate, and urinary bladder surgeries, as well as abdominal exploration.
  • surgery duration lasting longer than 2 hours.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rao Sun

Wuhan, China

Location

Study Officials

  • Rao Sun, Dr.

    Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

    PRINCIPAL INVESTIGATOR

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

July 7, 2023

First Posted

July 14, 2023

Study Start

July 20, 2023

Primary Completion

July 30, 2023

Study Completion

July 30, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)