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

NCT04153578 | Completed

• 1 other identifier: 057.PHA.2019.A
• Study Type: observational
• Target: 945
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Weight, Body

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  4/1/2017-8/31/2019

• Safety: in-hospital mortality, vasopressor-associated adverse events

  4/1/2017-8/31/2019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Non-sepsis indication for vasopressors
• Surgical or trauma admission type
• ICU length of stay \< 24 hours
• Pregnant

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Shock, Septic; Body Weight

Condition Hierarchy (Ancestors)

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

Study Officials

• Tamara Reiter, PharmD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: November 4, 2019
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)