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

Primary Purpose

Shock, Septic

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vasopressin
Norepinephrine
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring septic shock, vasopressin, norepinephrine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Norepinephrine and vasopressin

Norepinephrine

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Time to goal MAP

Secondary Outcome Measures

Full Information

First Posted
May 22, 2015
Last Updated
November 27, 2017
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT02454348
Brief Title
NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock
Acronym
NOVEL
Official Title
NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock (NOVEL Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI left
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
November 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic
Keywords
septic shock, vasopressin, norepinephrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Norepinephrine and vasopressin
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Norepinephrine
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
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 Measure Information:
Title
Time to goal MAP
Time Frame
Within 28 days of therapy initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years (no maximum age) At least 2 of 4 systemic inflammatory response syndrome criteria: Fever (>38°C) or hypothermia (<36°C), Tachycardia (heart rate >90 bpm), Tachypnea (respiratory rate >20 breaths/min or partial pressure of carbon dioxide <4.3 kPa) or need for mechanical ventilation, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drayton Hammond, Pharm.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29600824
Citation
Hammond DA, Ficek OA, Painter JT, McCain K, Cullen J, Brotherton AL, Kakkera K, Chopra D, Meena N. Prospective Open-label Trial of Early Concomitant Vasopressin and Norepinephrine Therapy versus Initial Norepinephrine Monotherapy in Septic Shock. Pharmacotherapy. 2018 May;38(5):531-538. doi: 10.1002/phar.2105. Epub 2018 Apr 30.
Results Reference
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NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock

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