Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

Sponsor

Taipei Medical University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05455528

Collaborator

(none)

2,421,286

Enrollment

Location

5.9

Actual Duration (Months)

407170.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency Morality	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 Design

Study Type:

Observational

Actual Enrollment :

2421286 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Risk of postoperative mortality [30 days after surgery date]
Calculate risk of postoperative 30-day in-hospital mortality between groups

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University Hospital	Taipei	Taiwan ( R.o.c.)	Taiwan	110

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chao-Shun Lin, principal investigator, Taipei Medical University Hospital

ClinicalTrials.gov Identifier:

NCT05455528

Other Study ID Numbers:

202206019

First Posted:

Jul 13, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Study Results

No Results Posted as of Jul 13, 2022