Clinical trial NCT04153578: Time to Lose the Weight? Comparison of Weight-based and Non-weight-based Vasopressors for Septic Shock
Official title: Time to Lose the Weight? Comparison of Weight-based and Non-weight-based Vasopressors for Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Weight, Body
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to MDMC and MCMC from 4/1/2017-8/31/2019 will be identified through the electronic medical record utilizing ICD codes for sepsis and septic shock.

Brief summary: At present, there is conflicting evidence regarding outcomes in patients with septic shock receiving weight-based vasopressor (WBVP) versus non-weight-based vasopressor (NWBVP) dosing strategies. At MCMC, a weight-based strategy is in place whereas MDMC, MMMC and MRMC currently utilize a non-weight-based dosing strategy. Obese patients (BMI \> 30) receiving either strategy may potentially be receiving substantially more or less vasopressor exposure compared to their non-obese (BMI \< 30) counterparts. Determining total vasopressor exposure and assessing clinical outcomes would benefit our institution and others by providing optimal vasopressor dosing strategies in obese and non-obese patients. There is a difference in clinical outcomes between patients receiving weight-based and non-weight-based vasopressor dosing strategies. There is a difference in total vasopressor exposure between obese and non-obese patients utilizing WBVP and NWBVP strategies.

Detailed description: Vasopressors are a mainstay of therapy for patients with septic shock to achieve and maintain hemodynamic stability.1 Both weight-based and non-weight-based dosing recommendations exist with no clear evidence that one is better than the other.3-10 However, in light of the obesity epidemic and emerging evidence regarding the dangers of excessive catecholamine exposure, an evaluation of dosing practices is warranted. The aim of this study is to determine whether clinical outcomes differ between patients receiving weight-based and non-weight-based vasopressor dosing strategies for septic shock. This is a multicenter, retrospective chart review. Patients admitted to MDMC and MCMC from 4/1/2017-8/31/2019 will be identified through the electronic medical record utilizing ICD codes for sepsis and septic shock. Patients meeting study inclusion criteria will be analyzed as described below. Outcomes will be assessed between patients receiving WBVP and NWBVP with planned subgroup analysis in each group between patients with BMI \< 30, 30-49, and \> 50.

Eligibility criteria: Inclusion Criteria:

* ICU admission
* Medical admission type
* Received NE, epinephrine (EPI), phenylephrine (PE), or dopamine (DA) for septic shock
* Received NE/EPI/PE/DA for \> 24 hours
* Age ≥ 18 years

Exclusion Criteria:

* Non-sepsis indication for vasopressors
* Surgical or trauma admission type
* ICU length of stay \< 24 hours
* Pregnant

Primary outcomes:
measure: Efficacy: Total 48-hour vasopressor exposure
timeFrame: 4/1/2017-8/31/2019
measure: Safety: Composite of in-hospital mortality, vasopressor-associated adverse events
timeFrame: 4/1/2017-8/31/2019
Secondary outcomes:
measure: Efficacy: Total number of vasoactive agents required to maintain mean arterial pressure
timeFrame: 4/1/2017-8/31/2019
measure: Safety: in-hospital mortality, vasopressor-associated adverse events
timeFrame: 4/1/2017-8/31/2019
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Tamara Reiter, PharmD
role: PRINCIPAL_INVESTIGATOR
References: