A Randomized Double Blind Trial of Vasoactive Drugs for the Management of Shock in the ICU

14-0047

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.

2014-05-01

2024-12-01

2025-12-01

Recruiting

Early phase I

836

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 836, 'type': 'ESTIMATED'}}

2023-12-21