Comparing vasoactive drugs for treating shock in ICU patients
A Randomized Double Blind Trial of Vasoactive Drugs for the Management of Shock in the ICU
This study tests whether using phenylephrine and vasopressin can help ICU patients in shock feel better compared to the usual treatments of norepinephrine and epinephrine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 836 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT02118467 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of vasoactive drugs phenylephrine and vasopressin compared to norepinephrine and epinephrine in ICU patients experiencing shock that is unresponsive to IV fluids. It is a randomized double-blind controlled trial conducted at the University of Chicago, focusing on reducing tachydysrhythmias associated with shock treatment. The study aims to provide evidence-based guidance on the choice of vasoactive medications in critical care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require vasoactive drugs for shock treatment.
Not a fit: Patients with cardiopulmonary arrest, pregnancy, or severe right heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for ICU patients with shock by minimizing the risk of tachydysrhythmias.
How similar studies have performed: While there have been limited studies comparing these specific vasoactive medications, previous research has indicated that the choice of medication often lacks a solid evidence base, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age greater than or equal to 18 years old 2. Requirement for vasoactive drugs via a central venous catheter for the treatment of shock. Shock will be defined as mean arterial pressure less than 70 mmHg or systolic blood pressure less than 100 mmHg despite administration of at least 1000 mL of crystalloid or 500 mL of colloid, unless there is an elevation in the central venous pressure to \> 12 mmHg or in the pulmonary artery occlusion pressure to \> 14 mmHg coupled with signs of tissue hypoperfusion (e.g. altered mental state, mottled skin, urine output \< 0.5 mL/kg body weight for one hour, or a serum lactate level of \> 2 mmol per liter). Exclusion Criteria: 1. Cardiopulmonary arrest 2. Pregnancy 3. Severe right heart failure
Where this trial is running
Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: John P Kress, MD — University of Chicago
- Study coordinator: John P Kress, MD
- Email: jkress@medicine.bsd.uchicago.edu
- Phone: 773-702-6404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.