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

Completed

• Conditions: Septic Shock; Weight, Body

• Registration Number: NCT04153578
• Lead Sponsor: Methodist Health System

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.

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 945

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States