- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04817722
Hydration During Thoracic Surgery
March 23, 2021 updated by: Ochsner Health System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
222
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients 18 years of age or older who required thoracic surgery.
Description
Inclusion Criteria:
- All patients requiring thoracic surgery
Exclusion Criteria:
- Patients less than 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Length of Stay
Time Frame: 30 days
|
Hospital Length of Stay
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bobby D Nossaman, MD, Ochsner Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 12, 2014
Primary Completion (ACTUAL)
January 31, 2016
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (ACTUAL)
March 26, 2021
Study Record Updates
Last Update Posted (ACTUAL)
March 26, 2021
Last Update Submitted That Met QC Criteria
March 23, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- OchsnerHS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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