Hospital Length of Stay; Adverse EventsNCT04817722
Hydration During Thoracic Surgery
An observational study of Hospital Length of Stay; Adverse Events, run by Ochsner Health System.
Trial summary
The purpose of this retrospective study was to analyze the role of intraoperative crystalloid administration on postoperative hospital length of stay and on the incidence of previously reported adverse events following thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hospital Length of Stay; Adverse Events
- What is being tested?
- Intravenous Solution
- Type of treatment
- Injection or infusion
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2014to 1 Jun 2016
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients 18 years of age or older who required thoracic surgery.
Who may be able to join
- All patients requiring thoracic surgery
Who cannot join
- Patients less than 18 years of age
About this study
Official title: THORACIC SURGERY: A RETROSPECTIVE STUDY TO DISCOVER ANESTHETIC PREDICTORS FOR INCREASED HOSPITAL LENGTH OF STAY AND ADVERSE EVENTS
The purpose of this retrospective study was to analyze the role of intraoperative crystalloid administration on postoperative hospital length of stay and on the incidence of previously reported adverse events following thoracic surgery.
Read the detailed description
The role of intraoperative crystalloid administration, when expressed as dose-response curves, on the duration of hospital length of stay (hLOS) and on previously reported incidences of surgical, cardiovascular, pulmonary, renal, other, and long-term AEs was evaluated with F-ratio statistics or with Chi-square tests set at a more stringent P<.01 value for significance to reduce the incidence of false discovery rates. Loglinear variance was utilized to examine the role of postoperative hLOS residuals across the range of intraoperative crystalloid administration. Multivariable analysis screened those previously reported independent variables with P<.1 with length of surgery, and the a posteriori variable of interest, rate of intraoperative crystalloid administration on duration of hLOS in a stepwise fashion with a maximum 5-fold R2 stopping rule, a cross validation technique that chooses the best model. The multivariable analysis was repeated with a regional instrumental variable based upon state residency to represent unmeasured confounders in this population that may have an association with the outcome of interest. Variance inflation factors calculations were conducted to determine the role of multicollinearity by the independent variables of interest. Sample size calculations for multivariable analysis require a minimum of 100 patients with ≥200 the preferred sample size. Recursive partitioning with 5-fold cross-validation, a measure of internal model validation, examined administration rates of intraoperative crystalloid administration by quantiles on hLOS and the role of intraoperative transfusion of pRBCs on hLOS. Tests to support the likelihood of causality of the intraoperative crystalloid administration on duration of hLOS was examined following analysis of seven likelihood tests; published findings consistent with prior research, biologic plausibility, dose-response relationship, strength of effect, and exclusions of effect-cause, confounding, and bias. The statistical program, JMP 13.2 (SAS Institute, Cary, NC) was utilized in this study.
- Conditions
- Hospital Length of Stay; Adverse Events
- Being tested
- Intravenous Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous SolutionDrug
Intraoperative hydration
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Hospital Length of Stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start12 Dec 2014
- Primary completion31 Jan 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Length of Stay; Adverse EventsStudies 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
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bobby D Nossaman, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817722
- Sponsor's protocol ID
- OchsnerHS-001
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THORACIC SURGERY: A RETROSPECTIVE STUDY TO DISCOVER ANESTHETIC PREDICTORS FOR INCREASED HOSPITAL LENGTH OF STAY AND ADVERSE EVENTS
- ClinicalTrials.gov ID
- NCT04817722
- Acronym / sponsor ID
- OchsnerHS-001
- Conditions
- Hospital Length of Stay; Adverse Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 26 Mar 2021 (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 purpose of this retrospective study was to analyze the role of intraoperative crystalloid administration on postoperative hospital length of stay and on the incidence of previously reported adverse events following thoracic surgery.
Detailed description
The role of intraoperative crystalloid administration, when expressed as dose-response curves, on the duration of hospital length of stay (hLOS) and on previously reported incidences of surgical, cardiovascular, pulmonary, renal, other, and long-term AEs was evaluated with F-ratio statistics or with Chi-square tests set at a more stringent P<.01 value for significance to reduce the incidence of false discovery rates. Loglinear variance was utilized to examine the role of postoperative hLOS residuals across the range of intraoperative crystalloid administration. Multivariable analysis screened those previously reported independent variables with P<.1 with length of surgery, and the a posteriori variable of interest, rate of intraoperative crystalloid administration on duration of hLOS in a stepwise fashion with a maximum 5-fold R2 stopping rule, a cross validation technique that chooses the best model. The multivariable analysis was repeated with a regional instrumental variable based upon state residency to represent unmeasured confounders in this population that may have an association with the outcome of interest. Variance inflation factors calculations were conducted to determine the role of multicollinearity by the independent variables of interest. Sample size calculations for multivariable analysis require a minimum of 100 patients with ≥200 the preferred sample size. Recursive partitioning with 5-fold cross-validation, a measure of internal model validation, examined administration rates of intraoperative crystalloid administration by quantiles on hLOS and the role of intraoperative transfusion of pRBCs on hLOS. Tests to support the likelihood of causality of the intraoperative crystalloid administration on duration of hLOS was examined following analysis of seven likelihood tests; published findings consistent with prior research, biologic plausibility, dose-response relationship, strength of effect, and exclusions of effect-cause, confounding, and bias. The statistical program, JMP 13.2 (SAS Institute, Cary, NC) was utilized in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 18 years of age or older who required thoracic surgery.
Key inclusion criteria (1 listed)
- All patients requiring thoracic surgery
Key exclusion criteria (1 listed)
- Patients less than 18 years of age
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 |
|---|---|---|
| Intravenous SolutionIntraoperative hydration | Drug | – |
Primary outcome
Hospital Length of Stay
Time frame: 30 days
Hospital Length of Stay
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 26 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hospital Length of Stay; Adverse Events
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Post-ERCP Adverse Events, ERCP Complications
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.
Bobby D Nossaman, MD principal investigator
Ochsner Health System
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital Length of Stay; Adverse Events, run by Ochsner Health System.
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 1 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 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Hospital Length of Stay (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2021.