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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

Page last updated: August 23, 2015

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