We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock (NOVEL)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02454348
Recruitment Status : Withdrawn (PI left)
First Posted : May 27, 2015
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
Sepsis, a systemic host response to the invasion of a pathogenic microorganism, may progress to severe sepsis, wherein the patient experiences acute dysfunction in at least one organ system, and further develop into septic shock if the patient cannot regain adequate systemic blood pressure and perfusion after adequate and appropriate fluid resuscitation. Further prospective study of the potential mortality benefit with combination norepinephrine and vasopressin in critically ill patients with septic shock needs to be performed. Our research will resolve this essential question and improve the scientific knowledge surrounding vasoactive medications in patients with septic shock.

Condition or disease Intervention/treatment Phase
Shock, Septic Drug: Vasopressin Drug: Norepinephrine Phase 4

Detailed Description:
Sepsis, a systemic host response to the invasion of a pathogenic microorganism, may progress to severe sepsis, wherein the patient experiences acute dysfunction in at least one organ system, and further develop into septic shock if the patient cannot regain adequate systemic blood pressure and perfusion after adequate and appropriate fluid resuscitation. The exact societal burden from severe sepsis and septic shock in difficult to quantify: millions of individuals in both industrialized and developing nations experience these syndromes each year, the best medical centers in the world have only achieved a 22% mortality rate for severe sepsis, and caregivers as well as patients endure a long-lasting impact from caring from loved ones who have survived severe sepsis. Recently, the impactful work performed by Rivers and colleagues that established early goal-directed therapy (EGDT) as the standard of care for patients with severe sepsis or septic shock has been compared to usual care in three international trials. The results of these trials suggest that usual care is as effective as EGDT, which necessitates new research be conducted into each component of EGDT to determine how and to what extent specific therapies are safe and effective. One key aspect of the provision of care to patients with septic shock is the time to initiation and choice of vasoactive agents. This study will investigate the use of norepinephrine and vasopressin versus norepinephrine alone as the initial vasoactive regimen in critically ill adult patients with septic shock.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock (NOVEL Trial)
Actual Study Start Date : November 1, 2015
Primary Completion Date : November 27, 2017
Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Norepinephrine and vasopressin
Norepinephrine (0.05 to 0.5 mcg/kg/min) and vasopressin (0.04 units/min) will be given by continuous infusion to achieve and maintain a target mean arterial pressure (65-75 mm Hg).
Drug: Vasopressin
Subjects will receive vasopressin (0.04 units/min) by continuous infusion to achieve and maintain a target mean arterial pressure (65-75 mm Hg). The treating physician may choose the initial dosage of norepinephrine within the initial range of 0.05-0.5 mcg/kg/min. The treating physician may alter the target mean arterial pressure if clinically indicated.
Drug: Norepinephrine
Subjects will receive norepinephrine (0.05 to 0.5 mcg/kg/min) by continuous infusion with titration by bedside nurse to achieve and maintain a target mean arterial pressure (65-75 mm Hg). The treating physician may choose the initial dosage of norepinephrine within the initial range of 0.05-0.5 mcg/kg/min. The treating physician may alter the target mean arterial pressure if clinically indicated.
Active Comparator: Norepinephrine
Norepinephrine (0.05 to 0.5 mcg/kg/min) will be given by continuous infusion to achieve and maintain a target mean arterial pressure (65-75 mm Hg).
Drug: Norepinephrine
Subjects will receive norepinephrine (0.05 to 0.5 mcg/kg/min) by continuous infusion with titration by bedside nurse to achieve and maintain a target mean arterial pressure (65-75 mm Hg). The treating physician may choose the initial dosage of norepinephrine within the initial range of 0.05-0.5 mcg/kg/min. The treating physician may alter the target mean arterial pressure if clinically indicated.



Primary Outcome Measures :
  1. Time to goal MAP [ Time Frame: Within 28 days of therapy initiation ]


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:

  • Age ≥18 years (no maximum age)
  • At least 2 of 4 systemic inflammatory response syndrome criteria:

    1. Fever (>38°C) or hypothermia (<36°C),
    2. Tachycardia (heart rate >90 bpm),
    3. Tachypnea (respiratory rate >20 breaths/min or partial pressure of carbon dioxide <4.3 kPa) or need for mechanical ventilation,
    4. Abnormal leucocyte count (>12000 cells/mm3, <4000 cells/mm3 or >10% immature (band) forms).
  • Hypotension despite adequate intravenous fluid resuscitation (minimum 20 mL/kg within the previous 4 hours)
  • Clinical suspicion for or confirmation of an infection
  • Admitted or being admitted to the medical intensive care unit

Exclusion Criteria:

  • End-stage renal disease requiring long-term dialysis
  • Pregnant
  • Not expected to be alive within 48 hours of enrollment
  • Receipt of a continuous infusion of vasoactive medication(s) other than use for emergency stabilization of blood pressure (for less than 4 hours)
  • Enrollment in another clinical trial within 30 days

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): NCT02454348


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Drayton Hammond, Pharm.D. University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02454348     History of Changes
Other Study ID Numbers: 204265
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Arkansas:
septic shock
vasopressin
norepinephrine

Additional relevant MeSH terms:
Shock
Critical Illness
Shock, Septic
Pathologic Processes
Disease Attributes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Benzocaine
Norepinephrine
Vasopressins
Arginine Vasopressin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents