Early Use of Norepinephrine in Septic Shock Resuscitation
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock; Severe Sepsis
Intervention: Early norepinephrine (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Chairat Permpikul, MD, Principal Investigator, Affiliation: Mahidol University
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.
Clinical Details
Official title: The Comparison Between Early Norepinephrine Use and Standard Treatment During Severe Sepsis and Septic Shock Resuscitation.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Therapeutic goal achievement
Secondary outcome: Mortality rate
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Siriraj Hospital, Bangkok 10700, Thailand; Recruiting
Chairat Permpikul, MD, Phone: 0814081676, Email: sicpk@mahidol.ac.th
Tanuwong Viarasilpa, MD, Phone: 0813469400, Email: tanuwongviarasilpa@hotmail.com
Chairat Permpikul, MD, Principal Investigator
Tanuwong Viarasilpa, MD, Sub-Investigator
Surat Tongyoo, MD, Sub-Investigator
Additional Information
Starting date: September 2013
Last updated: April 17, 2015
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