NCT02118467 Vasoactive Drugs in Intensive Care Unit
| NCT ID | NCT02118467 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Chicago |
| Condition | Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 836 participants |
| Start Date | 2014-05-15 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 836 participants in total. It began in 2014-05-15 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators hypothesis is that for ICU patients with shock, the use of the vasoactive drugs phenylephrine and vasopressin will reduce tachydysrhythmias when compared to norepinephrine and epinephrine. To investigate this hypothesis, the investigators are conducting a randomized double blind controlled trial comparing phenylephrine and vasopressin vs. norepinephrine and epinephrine in ICU patients with shock that is not responsive to IV fluids. All patients admitted to the adult intensive care units at the University of Chicago will be screened for eligibility.
Eligibility 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
Contact & Investigator
John P Kress, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT02118467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02118467 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02118467 currently recruiting?
Yes, NCT02118467 is actively recruiting participants. Contact the research team at jkress@medicine.bsd.uchicago.edu for enrollment information.
Where is the NCT02118467 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT02118467 clinical trial?
NCT02118467 is sponsored by University of Chicago. The principal investigator is John P Kress, MD at University of Chicago. The trial plans to enroll 836 participants.