Septic Shock, Severe Sepsis
Conditions
Keywords
Septic shock, Severe sepsis, Norepinephrine
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.
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.
Interventions
DRUGEarly norepinephrine
Initiation of norepinephrine, a strong vasoconstrictor, at the initiation of septic shock management, together with fluid resuscitation.
DRUGPlacebo
5% dextrose water intravenous drip in the same rate of calculated norepinephrine for the patient's body weight
Sponsors
Siriraj Hospital
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic goal achievement | 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
| Measure | Time frame |
|---|---|
| Mortality rate | 28 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Survive with organ support free days | 28 days | The days that patient can survive without vasopressor, ventilator support and renal replacement therapy. |
Countries
Thailand
Outcome results
None listed