Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes: A Matched Cohort Study Using the NSQIP Database

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

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency; Morality
• Intervention / Treatment: Diagnostic test: estimated GFR calculation

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 Type: Observational
• Enrollment (Actual): 2421286

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan ( R.o.c.)
    • Taipei, Taiwan ( R.o.c.), Taiwan, 110
      • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
renal insufficiency group; Surgical population currently on dialysis; 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; The estimated GFR is computed with Modification of Diet in Renal Disease (MDRD) formula
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; The estimated GFR is computed with Modification of Diet in Renal Disease (MDRD) formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of postoperative mortality	Calculate risk of postoperative 30-day in-hospital mortality between groups	30 days after surgery date

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Investigators: Study Chair: Chao-Shun Lin, MD, PhD, Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: July 3, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 202206019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No