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

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.

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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