Shock, SepticPhase 4NOVELNCT02454348
NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock
A Phase 4 study testing Vasopressin and Norepinephrine in people with Shock, Septic, run by University of Arkansas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- Vasopressin and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 27 Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock (NOVEL Trial)
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.
Read the 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.
- Conditions
- Shock, Septic
- Being tested
- Vasopressin, Norepinephrine
- Keywords
- septic shock, vasopressin, norepinephrine
- Medical subject headings
- Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
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.
NorepinephrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Norepinephrine and vasopressin | Active comparator | 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). Receives: Drug: Vasopressin; Drug: Norepinephrine |
| Norepinephrine | Active comparator | 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). Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to goal MAP
Measured: Within 28 days of therapy initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study start1 Nov 2015
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drayton Hammond, Pharm.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454348
- Sponsor's protocol ID
- 204265
- Acronym
- NOVEL
- Status last verified
- Nov 2017
- First submitted
- 22 May 2015
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29600824
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock (NOVEL Trial)
- ClinicalTrials.gov ID
- NCT02454348
- Acronym / sponsor ID
- NOVEL / 204265
- Conditions
- Shock, Septic
- Keywords
- septic shock, vasopressin, norepinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norepinephrine and vasopressin | Active comparator | Drug: Vasopressin, Drug: NorepinephrineNorepinephrine (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 | Active comparator | Drug: NorepinephrineNorepinephrine (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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years (no maximum age)
- At least 2 of 4 systemic inflammatory response syndrome criteria:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinSubjects 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 and vasopressin |
| NorepinephrineSubjects 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. | Drug | Norepinephrine, Norepinephrine and vasopressin |
Primary outcome
Time to goal MAP
Time frame: Within 28 days of therapy initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Derived from this study: PubMed 29600824Hammond 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.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Drayton Hammond, Pharm.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vasopressin and Norepinephrine in people with Shock, Septic, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to goal MAP (time frame: Within 28 days of therapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.