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NCT Number: NCT04153578

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.

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Key information

Conditions

Septic Shock Body Weight Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Signs and Symptoms Systemic Inflammatory Response Syndrome Weight, Body

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Efficacy: Total 48-hour vasopressor exposure

    Time frame: 4/1/2017-8/31/2019

    Total 48-hour vasopressor exposure (norepinephrine (NE) equivalents, mg)

  2. Safety: Composite of in-hospital mortality, vasopressor-associated adverse events

    Time frame: 4/1/2017-8/31/2019

    Composite of in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)

Secondary outcomes

  1. Efficacy: Total number of vasoactive agents required to maintain mean arterial pressure

    Time frame: 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

  2. Safety: in-hospital mortality, vasopressor-associated adverse events

    Time frame: 4/1/2017-8/31/2019

    in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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