Shock Clinical Trial
Official title:
A Randomized Double Blind Trial of Vasoactive Drugs for the Management of Shock in the ICU
NCT number | NCT02118467 |
Other study ID # | 14-0047 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 836 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospital length of stay | Six months | ||
Other | Discharge location | i.e. to home, skilled nursing facility, nursing home, rehabilitation | Six months | |
Other | ICU Complications | Including the following: Ventilator associated pneumonia Barotrauma Gastrointestinal hemorrhage Pulmonary embolism Sacral decubitus ulcer Delirium ICU acquired weakness |
Six months | |
Other | ICU length of stay | Six months | ||
Other | Duration of mechanical ventilation | Six months | ||
Other | Functional status | Categorized as independent or not independent, based on ability to perform 6 activities of daily living (ADLs) and ability to walk. | one month, three months, six months, and twelve months after discharge | |
Other | Immune cell function | cytokine levels | 1 week | |
Primary | Hospital mortality | Six months | ||
Secondary | Heart rate | Six months | ||
Secondary | Incidence of tachydysrhythmia | Including both atrial arrhythmias (i.e. atrial fibrillation, atrial flutter) as well as ventricular dysrhythmias | SIx months |
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