Time to Lose the Weight? Comparison of Weight-based and Non-weight-based Vasopressors for Septic Shock

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Weight, Body

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.

• Study Type: Observational
• Enrollment (Actual): 945

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Total 48-hour vasopressor exposure	Total 48-hour vasopressor exposure (norepinephrine (NE) equivalents, mg)	4/1/2017-8/31/2019
Safety: Composite of in-hospital mortality, vasopressor-associated adverse events	Composite of in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)	4/1/2017-8/31/2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Total number of vasoactive agents required to maintain mean arterial pressure	Total number of vasoactive agents required to maintain mean arterial pressure (MAP) > 65 mmHg, time to hemodynamic stability, use of angiotensin II or vasopressin	4/1/2017-8/31/2019
Safety: in-hospital mortality, vasopressor-associated adverse events	in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)	4/1/2017-8/31/2019

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Tamara Reiter, PharmD, Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): June 22, 2020
• Study Completion (Actual): June 22, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Body Weight
• Other Study ID Numbers: 057.PHA.2019.A

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: No
• Studies a U.S. FDA-regulated device product: No