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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Morality
• Renal Insufficiency

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