Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04817722 |
| Other study ID # |
OchsnerHS-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 12, 2014 |
| Est. completion date |
June 1, 2016 |
Study information
| Verified date |
March 2021 |
| Source |
Ochsner Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
