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Vasoactive Drugs in Intensive Care Unit

ConditionShock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to 18 years old

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).

Disqualifiers

Cardiopulmonary arrest

Pregnancy

Severe right heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

836 Participants
are divided into 2 treatment groups
Group A: Norepinephrine and epinephrineActive comparator 2 interventions
Group B: Phenylephrine and vasopressinActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Hospital mortality

Time frame
Six months

Secondary outcomes

1

Heart rate

Time frame
Six months
2

Incidence of tachydysrhythmia

Including both atrial arrhythmias (i.e. atrial fibrillation, atrial flutter) as well as ventricular dysrhythmias

Time frame
SIx months

Other outcomes

1

Hospital length of stay

Time frame
Six months
2

Discharge location

i.e. to home, skilled nursing facility, nursing home, rehabilitation

Time frame
Six months
3

ICU Complications

Including the following: 1. Ventilator associated pneumonia 2. Barotrauma 3. Gastrointestinal hemorrhage 4. Pulmonary embolism 5. Sacral decubitus ulcer 6. Delirium 7. ICU acquired weakness

Time frame
Six months
4

ICU length of stay

Time frame
Six months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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