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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04153578
Enrollment
945
Registered
2019-11-06
Start date
2019-11-04
Completion date
2020-06-22
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock, Weight, Body

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.

Interventions

None listed

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Efficacy: Total 48-hour vasopressor exposure4/1/2017-8/31/2019Total 48-hour vasopressor exposure (norepinephrine (NE) equivalents, mg)
Safety: Composite of in-hospital mortality, vasopressor-associated adverse events4/1/2017-8/31/2019Composite of in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)

Secondary

MeasureTime frameDescription
Efficacy: Total number of vasoactive agents required to maintain mean arterial pressure4/1/2017-8/31/2019Total number of vasoactive agents required to maintain mean arterial pressure (MAP) \> 65 mmHg, time to hemodynamic stability, use of angiotensin II or vasopressin
Safety: in-hospital mortality, vasopressor-associated adverse events4/1/2017-8/31/2019in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTamara Reiter, PharmD

The Methodist Hospital Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026