NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock

• Status: Withdrawn
• Trial end date: 2017-11-27
• Target enrollment: 0
• Participant gender: All

Summary

Sepsis, a systemic host response to the invasion of a pathogenic microorganism, may progress to severe sepsis, wherein the patient experiences acute dysfunction in at least one organ system, and further develop into septic shock if the patient cannot regain adequate systemic blood pressure and perfusion after adequate and appropriate fluid resuscitation. Further prospective study of the potential mortality benefit with combination norepinephrine and vasopressin in critically ill patients with septic shock needs to be performed. Our research will resolve this essential question and improve the scientific knowledge surrounding vasoactive medications in patients with septic shock.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Arginine Vasopressin; Benzocaine; Norepinephrine; Vasopressins

Criteria

Inclusion Criteria:

• Age ≥18 years (no maximum age)

• At least 2 of 4 systemic inflammatory response syndrome criteria:

1. Fever (>38°C) or hypothermia (<36°C),

2. Tachycardia (heart rate >90 bpm),

3. Tachypnea (respiratory rate >20 breaths/min or partial pressure of carbon dioxide <4.3 kPa) or need for mechanical ventilation,

4. Abnormal leucocyte count (>12000 cells/mm3, <4000 cells/mm3 or >10% immature (band) forms).

• Hypotension despite adequate intravenous fluid resuscitation (minimum 20 mL/kg within the previous 4 hours)

• Clinical suspicion for or confirmation of an infection

• Admitted or being admitted to the medical intensive care unit

Exclusion Criteria:

• End-stage renal disease requiring long-term dialysis

• Pregnant

• Not expected to be alive within 48 hours of enrollment

• Receipt of a continuous infusion of vasoactive medication(s) other than use for emergency stabilization of blood pressure (for less than 4 hours)

• Enrollment in another clinical trial within 30 days