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NCT05455528 Clinical Trial

Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

Renal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05455528
Other study ID # 202206019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date July 1, 2022

Study information
Verified date July 2022
Source Taipei Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 2421286
Est. completion date July 1, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• estimated GFR calculation
The estimated GFR is computed with Modification of Diet in Renal Disease (MDRD) formula

Locations
Country Name City State
Taiwan Taipei Medical University Hospital Taipei Taiwan ( R.o.c.)

Sponsors (1)
Lead Sponsor Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Risk of postoperative mortality Calculate risk of postoperative 30-day in-hospital mortality between groups 30 days after surgery date
Secondary 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
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