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Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER)

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ClinicalTrials.gov Identifier: NCT01945983
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : January 9, 2018
Siriraj Hospital
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
Current septic shock guideline recommends fluid resuscitation as the first treatment. Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid therapy. This can cause a certain duration of systemic hypotension before vasopressor is commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of septic shock may increase blood pressure quicker than start treatment with intravenous fluid alone. The rapid restoration of perfusion pressure may improve septic shock outcome.

Condition or disease Intervention/treatment Phase
Septic Shock Severe Sepsis Drug: Early norepinephrine Drug: Placebo Not Applicable

Detailed Description:

We will include severe infection patient who had evidence of organ dysfunction and hypotension and randomize into 2 groups as following:

  1. Control group. The patient will receive treatment according to septic shock guideline 2013, which start with intravenous fluid replacement until achieve target central venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP) or other fluid responsive test goal. If the patient's mean arterial blood pressure still lower than 65 mmHg, then norepinephrine or dopamine will initiate to rise blood pressure. The patient will receive 5% dextrose water as the placebo of norepinephrine.
  2. Early norepinephrine group. The patient will receive fluid therapy together with low dose of norepinephrine (0.05 mcg/kg/min). If after titrate intravenous fluid therapy until achieve goal CVP or PCWP or other fluid responsive test, but the mean blood pressure still lower than 65 mmHg, then additional titrate dose of norepinephrine will be given to the patient according to standard septic shock guideline.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison Between Early Norepinephrine Use and Standard Treatment During Severe Sepsis and Septic Shock Resuscitation.
Actual Study Start Date : October 3, 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Active Comparator: Early norepinephrine
Norepinephrine 4 mg in 5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour, adjusted according to patient's body weight to achieve norepinephrine 0.05microgram/kg/min Continuous drip for 48 hours.
Drug: Early norepinephrine
Initiation of norepinephrine, a strong vasoconstrictor, at the initiation of septic shock management, together with fluid resuscitation.
Other Name: Early vasopressor therapy

Placebo Comparator: Placebo
5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour. Adjust rate of infusion according to patient's body weight to achieve dosage of norepinephrine comparable to 0.05 microgram/kg/min Continuous drip for 48 hours.
Drug: Placebo
5% dextrose water intravenous drip in the same rate of calculated norepinephrine for the patient's body weight
Other Name: 5%D/W infusion as the placebo of norepinephrine.

Primary Outcome Measures :
  1. Therapeutic goal achievement [ Time Frame: 6 hours ]

    Therapeutic goal including

    1. Mean arterial blood pressure > or = 65 mmHg
    2. Evidence of adequate tissue perfusion which include continuation of urine output > or = 0.5 ml/kg/hour for 2 hours or decreasing of serum lactate > or = 10 percent in 1 to 2 hours.

Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 28 days ]

Other Outcome Measures:
  1. Survive with organ support free days [ Time Frame: 28 days ]
    The days that patient can survive without vasopressor, ventilator support and renal replacement therapy.

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

Inclusion Criteria:

  • Age > or = 18 years old
  • Diagnosed severe sepsis or septic shock according to survival sepsis campaign 2013
  • Mean arterial pressure < 65 mmHg

Exclusion Criteria:

  • Pregnancy
  • Severe underlying condition that unexpected to survive more than 48 hours
  • Severe peripheral vascular disease
  • Patient who required major surgery within 24 hours

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): NCT01945983

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Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
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Principal Investigator: Chairat Permpikul, MD Mahidol University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01945983    
Other Study ID Numbers: Si507/2013
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by Mahidol University:
Septic shock
Severe sepsis
Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents