Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

Completed

• Conditions: Renal Insufficiency; Morality
• Interventions: Diagnostic Test: estimated GFR calculation

• Registration Number: NCT05455528
• Lead Sponsor: Taipei Medical University Hospital

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.

Detailed Description

This retrospective cohort study use the National Surgical Quality Improvement Program (NSQIP) database to evaluate the risk of postoperative morbidity and mortality in the surgical population. Patients with estimated. glomerular filtration rate(GFR) \< 60 ml/min per 1.73 square meter are defined as the renal insufficiency group. Patients with estimated GFR \> 90 ml/min per 1.73 square meter are defined as patients without renal insufficiency. Propensity score-matching methods and multivariate logistic regression are used to calculate the risk of postoperative morbidity and mortality.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-06-30
• Status Verified: 2022-07
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2421286

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-renal insufficiency group	estimated GFR calculation	Defined as the study subjects with eGFR \> 90 60 ml/min per 1.73 square meter within 90 days before the index surgery
renal insufficiency group	estimated GFR calculation	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

Primary Outcome Measures

Name	Time	Method
Risk of postoperative mortality	30 days after surgery date	Calculate risk of postoperative 30-day in-hospital mortality between groups

Secondary Outcome Measures

Name	Time	Method
Risk of postoperative morbidities	30 days after surgery date	Postoperative events, including pneumonia, septic shock, stroke, deep vein thrombosis/thrombophlebitis, myocardial infarction and postoperative bleeding are included

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan ( R.o.c.), Taiwan