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Completed

NCT Number: NCT01945983

Early Use of Norepinephrine in Septic Shock Resuscitation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early norepinephrine

Drug

Initiation of norepinephrine, a strong vasoconstrictor, at the initiation of septic shock management, together with fluid resuscitation.

Other names: Early vasopressor therapy

Placebo

Drug

5% dextrose water intravenous drip in the same rate of calculated norepinephrine for the patient's body weight

Other names: 5%D/W infusion as the placebo of norepinephrine.

Primary outcomes

  1. Therapeutic goal achievement

    Time frame: 6 hours

    Therapeutic goal including

    • Mean arterial blood pressure > or = 65 mmHg
    • 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 outcomes

  1. Mortality rate

    Time frame: 28 days

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Siriraj Hospital

Registry information

Official study title

The Comparison Between Early Norepinephrine Use and Standard Treatment During Severe Sepsis and Septic Shock Resuscitation.

Acronym: CENSER

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2013
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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