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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153578
• Other study ID #: 057.PHA.2019.A
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: June 22, 2020

Study information

• Verified date: November 2021
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 945
• Est. completion date: June 22, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Septic Shock
• Shock
• Shock, Septic
• Weight, Body

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Total 48-hour vasopressor exposure	Total 48-hour vasopressor exposure (norepinephrine (NE) equivalents, mg)	4/1/2017-8/31/2019
Primary	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	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
Secondary	Safety: in-hospital mortality, vasopressor-associated adverse events	in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)	4/1/2017-8/31/2019