Early Use of Norepinephrine in Septic Shock Resuscitation

Septic Shock Clinical Trial

— CENSER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945983
• Other study ID #: Si507/2013
• Status: Completed
• Phase: N/A
• First received: September 16, 2013
• Last updated: January 8, 2018
• Start date: October 3, 2013
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic

Intervention

Drug:
• Early norepinephrine
Initiation of norepinephrine, a strong vasoconstrictor, at the initiation of septic shock management, together with fluid resuscitation.
• Placebo
5% dextrose water intravenous drip in the same rate of calculated norepinephrine for the patient's body weight

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survive with organ support free days	The days that patient can survive without vasopressor, ventilator support and renal replacement therapy.	28 days
Primary	Therapeutic goal achievement	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.	6 hours
Secondary	Mortality rate		28 days