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
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock Severe Sepsis||Drug: Early norepinephrine Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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.
- Mortality rate [ Time Frame: 28 days ]
- Survive with organ support free days [ Time Frame: 28 days ]The days that patient can survive without vasopressor, ventilator support and renal replacement therapy.
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
|Bangkok, Thailand, 10700|
|Principal Investigator:||Chairat Permpikul, MD||Mahidol University|