Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

NCT05455528 | Completed

• 1 other identifier: 202206019
• Study Type: observational
• Target: 2,421,286
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the risk of postoperative mortality and complications in surgical populations with preoperative renal insufficiency.

Conditions

Renal Insufficiency; Morality

Outcome Measures

Primary Outcomes (1)

• Risk of postoperative mortality

  Calculate risk of postoperative 30-day in-hospital mortality between groups

  30 days after surgery date

Secondary Outcomes (1)

• Risk of postoperative morbidities

  30 days after surgery date

Study Arms (2)

renal insufficiency group

1. Surgical population currently on dialysis 2. Surgical population with estimated GFR \< 60 ml/min per 1.73 square meter within 90days before the index surgery. The estimated GFR

Diagnostic Test: estimated GFR calculation

Non-renal insufficiency group

Defined as the study subjects with eGFR \> 90 60 ml/min per 1.73 square meter within 90 days before the index surgery

Diagnostic Test: estimated GFR calculation

Interventions

estimated GFR calculation DIAGNOSTIC_TEST

The estimated GFR is computed with Modification of Diet in Renal Disease (MDRD) formula

Non-renal insufficiency group; renal insufficiency group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study analyze surgical patient data from the American College of SurgeonsNational Surgical Quality Improvement Program (ACS-NSQIP) that was acquired between 2013 and 2018.

You may qualify if:

• Patients with estimated GFR \< 60 ml/min per 1.73 square meter or currently on dialysis are included in renal insufficiency group.
• Patients with estimated GFR \> 90 ml/min per 1.73 square meter are included in non-renal insufficiency group

You may not qualify if:

• Patients population with estimated GFR between 60-90 is not included in the study

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan ( R.o.c.), 110, Taiwan

Location

Related Publications (1)

• Liao YC, Chang CC, Chen CY, Liu CC, Liao CC, Shih YV, Lin CS. Preoperative renal insufficiency predicts postoperative adverse outcomes in a mixed surgical population: a retrospective matched cohort study using the NSQIP database. Int J Surg. 2023 Apr 1;109(4):752-759. doi: 10.1097/JS9.0000000000000278.

  PMID: 36974714 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Chao-Shun Lin, MD, PhD

  Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 13, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)