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Vasoactive Drugs in Intensive Care Unit

This study is currently recruiting participants.
Verified February 2017 by University of Chicago
Sponsor:
ClinicalTrials.gov Identifier:
NCT02118467
First Posted: April 21, 2014
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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.

Condition Intervention Phase
Shock Drug: Norepinephrine Drug: Epinephrine Drug: Phenylephrine Drug: Vasopressin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Trial of Vasoactive Drugs for the Management of Shock in the ICU

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Hospital mortality [ Time Frame: Six months ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: Six months ]
  • Incidence of tachydysrhythmia [ Time Frame: SIx months ]
    Including both atrial arrhythmias (i.e. atrial fibrillation, atrial flutter) as well as ventricular dysrhythmias


Other Outcome Measures:
  • Hospital length of stay [ Time Frame: Six months ]
  • Discharge location [ Time Frame: Six months ]
    i.e. to home, skilled nursing facility, nursing home, rehabilitation

  • ICU Complications [ Time Frame: Six months ]

    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

  • ICU length of stay [ Time Frame: Six months ]
  • Duration of mechanical ventilation [ Time Frame: Six months ]
  • Functional status [ Time Frame: one month, three months, six months, and twelve months after discharge ]
    Categorized as independent or not independent, based on ability to perform 6 activities of daily living (ADLs) and ability to walk.

  • Immune cell function [ Time Frame: 1 week ]
    cytokine levels


Estimated Enrollment: 836
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Norepinephrine
Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.
Other Name: Levophed
Drug: Epinephrine
Dose range 0.03 to 0.3 mcg/kg/minute, titrated to 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.

Drug: Phenylephrine
Dose range 0.3 to 3.0 mcg/kg/minute, titrated to target blood pressure.
Other Name: Neo-Synephrine
Drug: Vasopressin
Dose range 0.1 to 0.6 milliunits/kg/minute, titrated to target blood pressure.
Other Name: Pitressin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118467


Contacts
Contact: John P Kress, MD 773-702-6404 jkress@medicine.bsd.uchicago.edu
Contact: Jessica Cooksey, MD 773-702-1740 jessica.cooksey@uchospitals.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: John P Kress, MD    773-702-6404    jkress@medicine.bsd.uchicago.edu   
Contact: Anne S Pohlman, MSN    773-702-3804    apohlman@medicine.bsd.uchicago.edu   
Principal Investigator: John P Kress, MD         
Sub-Investigator: Jessica Cooksey, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: John P Kress, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02118467     History of Changes
Other Study ID Numbers: 14-0047
First Submitted: March 21, 2014
First Posted: April 21, 2014
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Chicago:
Shock
Vasopressor agents
Norepinephrine
Epinephrine
Phenylephrine
Vasopressin
Atrial fibrillation
Tachyarrhythmia

Additional relevant MeSH terms:
Shock
Pathologic Processes
Epinephrine
Racepinephrine
Phenylephrine
Oxymetazoline
Norepinephrine
Epinephryl borate
Vasopressins
Arginine Vasopressin
Vasoconstrictor Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Cardiotonic Agents
Nasal Decongestants
Adrenergic alpha-1 Receptor Agonists
Protective Agents
Hemostatics