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Completed

NCT Number: NCT05455528

Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

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

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Morality Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Medical University Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

estimated GFR calculation

Diagnostic Test

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

Primary outcomes

  1. Risk of postoperative mortality

    Time frame: 30 days after surgery date

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

Secondary outcomes

  1. Risk of postoperative morbidities

    Time frame: 30 days after surgery date

    Postoperative events, including pneumonia, septic shock, stroke, deep vein thrombosis/thrombophlebitis, myocardial infarction and postoperative bleeding are included

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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