Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes

NCT ID: NCT05455528

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2421286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Insufficiency Morality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

renal insufficiency group

1. Surgical population currently on dialysis
2. Surgical population with estimated GFR \< 60 ml/min per 1.73 square meter within 90days before the index surgery. The estimated GFR

estimated GFR calculation

Intervention Type DIAGNOSTIC_TEST

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

estimated GFR calculation

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

estimated GFR calculation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chao-Shun Lin

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chao-Shun Lin, MD, PhD

Role: STUDY_CHAIR

Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Medical University Hospital

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

Liao YC, Chang CC, Chen CY, Liu CC, Liao CC, Shih YV, Lin CS. Preoperative renal insufficiency predicts postoperative adverse outcomes in a mixed surgical population: a retrospective matched cohort study using the NSQIP database. Int J Surg. 2023 Apr 1;109(4):752-759. doi: 10.1097/JS9.0000000000000278.

Reference Type DERIVED
PMID: 36974714 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202206019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.