Vasoactive Drugs in Intensive Care Unit

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT02118467
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Norepinephrine — DRUG
    Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.
  • Epinephrine — DRUG
    Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.
  • Phenylephrine — DRUG
    Dose range 0.3 to 3.0 mcg/kg/minute, titrated to target blood pressure.
  • Vasopressin — DRUG
    Dose range 0.1 to 0.6 milliunits/kg/minute, titrated to target blood pressure.

Study Details

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.

Key Dates

Start date
May 15, 2014
Status verified
Dec 2025
Primary completion
Oct 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
836 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Norepinephrine and epinephrine
    Patients will receive norepinephrine infusion per standard protocol. Dose range will be 0.03-0.3 mcg/kg/minute. Norepinephrine concentration will be 16 mg/250 mL. If a second vasopressor is required, epinephrine will be added. Dose range of epinephrine will be 0.03-0.3 mcg/kg/minute. Epinephrine concentration will be 16 mg/250 mL. The drugs norepinephrine and epinephrine will be mixed and blinded by the research pharmacy. The research pharmacist will list the dose ranges in mL/hr; this will allow the bedside nurse to program the medication per standard protocol. If the patient's shock is not adequately treated with the highest doses of both norepinephrine and epinephrine, additional, open-label norepinephrine will be added, and titrated to achieve target blood pressure. If the patient's shock is not adequately treated with three vasopressors, additional open-label epinephrine will be added, and titrated to achieve target blood pressure.
  • Active Comparator: Phenylephrine and vasopressin
    Patients will receive phenylephrine infusion per standard protocol. Dose range will be 0.3 to 3.0 mcg/kg/minute. Phenylephrine concentration will be 160 mg/250 mL. If a second vasopressor is required, vasopressin will be added. Dose range of vasopressin will be 0.1 to 0.6 milliunits/kg/minute. Vasopressin concentration will be 40 units/250 mL. The drugs phenylephrine and vasopressin will be mixed and blinded by the research pharmacy. The research pharmacist will list the dose ranges in mL/hr; this will allow the bedside nurse to program the medication per standard protocol. If the patient's shock is not adequately treated with the highest doses of both phenylephrine and vasopressin, additional, open-label norepinephrine will be added, and titrated to achieve target blood pressure. If the patient's shock is not adequately treated with three vasopressors, additional open-label epinephrine will be added, and titrated to achieve target blood pressure.

Primary Outcome Measure

Hospital mortality [ Time Frame: Six months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
John P Kress, MD
[email protected]
773-702-6404
Anne S Pohlman, MSN
[email protected]
773-702-3804
John P Kress, MD (PRINCIPAL_INVESTIGATOR)
Jessica Cooksey, MD (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
University of Chicago Medical Center· Chicago, IL

Related Studies