Preoperative Nutritional Status and Postoperative Acute K... | NCT05945940

Studies
Preoperative Nutritional Status and Postoperative Acute Kidney Injury

NCT05945940

Sponsor

Rao Sun

Status

Completed

Last Update Posted

Oct 6, 2023Actual

Enrollment

2,977Actual

Phase

Not provided

Conditions

Postoperative Acute Kidney Injury

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2023Actual

Primary Completion Date

Jul 30, 2023Actual

Completion Date

Jul 30, 2023Actual

First Submitted Date

Jul 7, 2023

First Submission Date that Met QC Criteria

Jul 7, 2023

First Posted Date

Jul 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2023

Last Update Posted Date

Oct 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,977Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rao Sun, Dr.	Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rao Sun		Wuhan			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided