Renal InsufficiencyNCT05455528
Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes
An observational study of Renal Insufficiency and Morality, run by Taipei Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Insufficiency, Morality
- What is being tested?
- estimated GFR calculation
- How many people
- 2,421,286 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study analyze surgical patient data from the American College of SurgeonsNational Surgical Quality Improvement Program (ACS-NSQIP) that was acquired between 2013 and 2018.
Who may be able to join
- 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
Who cannot join
- Patients population with estimated GFR between 60-90 is not included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes: A Matched Cohort Study Using the NSQIP Database
The main purpose of this study is to evaluate the risk of postoperative mortality and complications in surgical populations with preoperative renal insufficiency.
Read the 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.
- Conditions
- Renal Insufficiency, Morality
- Being tested
- estimated GFR calculation
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estimated GFR calculationDiagnostic test
The estimated GFR is computed with Modification of Diet in Renal Disease (MDRD) formula
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: estimated GFR calculation | |
| 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 Receives: Diagnostic Test: estimated GFR calculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of postoperative mortality
Calculate risk of postoperative 30-day in-hospital mortality between groups
Measured: 30 days after surgery date
Secondary outcomes (1)
Risk of postoperative morbidities
Postoperative events, including pneumonia, septic shock, stroke, deep vein thrombosis/thrombophlebitis, myocardial infarction and postoperative bleeding are included
Measured: 30 days after surgery date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,421,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Shun Lin, Taipei Medical University Hospital
- Investigators
- Chao-Shun Lin, MD, PhD, Study chair, Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455528
- Sponsor's protocol ID
- 202206019
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36974714
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Renal Insufficiency Predicts Postoperative Adverse Outcomes: A Matched Cohort Study Using the NSQIP Database
- ClinicalTrials.gov ID
- NCT05455528
- Acronym / sponsor ID
- 202206019
- Conditions
- Renal Insufficiency, Morality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,421,286 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal insufficiency group | – | Diagnostic Test: estimated GFR calculation1. 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 |
| Non-renal insufficiency group | – | Diagnostic Test: estimated GFR calculationDefined as the study subjects with eGFR > 90 60 ml/min per 1.73 square meter within 90 days before the index surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study analyze surgical patient data from the American College of SurgeonsNational Surgical Quality Improvement Program (ACS-NSQIP) that was acquired between 2013 and 2018.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients population with estimated GFR between 60-90 is not included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estimated GFR calculationThe estimated GFR is computed with Modification of Diet in Renal Disease (MDRD) formula | Diagnostic test | Non-renal insufficiency group, renal insufficiency group |
Primary outcome
Risk of postoperative mortality
Time frame: 30 days after surgery date
Calculate risk of postoperative 30-day in-hospital mortality between groups
1 secondary outcome
Risk of postoperative morbidities
Time frame: 30 days after surgery date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Derived from this study: PubMed 36974714Liao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Shun Lin, MD, PhD study chair
Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency and Morality, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of postoperative mortality (time frame: 30 days after surgery date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05455528, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.