Recruiting

Vasoactive Drugs

Sponsor:

University of Chicago

Code:

NCT02118467

Conditions

Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Norepinephrine

Epinephrine

Phenylephrine

Vasopressin

Study Details

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.

Conditions

Shock

Study ID

NCT02118467

Start date

May 15, 2014

Status verified date

Dec, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

836 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Norepinephrine

Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.

Epinephrine

Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.

Phenylephrine

Dose range 0.3 to 3.0 mcg/kg/minute, titrated to target blood pressure.

Vasopressin

Dose range 0.1 to 0.6 milliunits/kg/minute, titrated to target blood pressure.

Primary outcome measure

  • Hospital mortality [ Time Frame: Six months ]

Central Contacts and Locations

Central contacts

John P Kress, MD

773-702-6404jkress@medicine.bsd.uchicago.edu

Anne Pohlman

6302487461apohlman@medicine.bsd.uchicago.edu

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

John P Kress, MD

773-702-6404jkress@medicine.bsd.uchicago.edu

Anne S Pohlman, MSN

773-702-3804apohlman@medicine.bsd.uchicago.edu

Principal Investigator:

John P Kress, MD

More Information

Sponsor

University of Chicago

Last update posted

Jan 13, 2026

Last verified

Dec, 2025

Keywords

  • Shock
  • Vasopressor agents
  • Norepinephrine
  • Epinephrine
  • Phenylephrine
  • Vasopressin
  • Atrial fibrillation
  • Tachyarrhythmia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-01-13.