Protocol-driven Hemodynamic Support for Patients With Septic Shock

Not Applicable

• Conditions: Shock, Septic; Severe Sepsis; Sepsis

• Registration Number: NCT00335907
• Lead Sponsor: National Institute of General Medical Sciences (NIGMS)

Brief Summary

This research is being done to see if a protocol (a set of orders that determine how much and how quickly a drug/fluid is given) for fluid and drugs used to increase blood pressure (vasopressors) will work better then general clinical practices to improve outcomes in patients with septic shock.

Detailed Description

Septic shock is low blood pressure caused by an infection. Sepsis is the most common cause of death in non-cardiac intensive care units, and septic shock is the most severe form of sepsis. Treatment for septic shock includes giving antibiotics, intravenous fluids, and medications to raise the blood pressure (vasopressors).

We would like to see if a protocol-driven management strategy for septic shock can shorten time on vasopressors and limit the number of side effects. We have constructed a protocol that will allow the nurse at the bedside, in conjunction with the physician's orders, to adjust the amount of fluids and medications that raise the blood pressure (vasopressors).

Study Timeline

• Study First Submitted: 2006-06-09
• Study First Submitted QC: 2006-06-09
• Study First Posted: 2006-06-12
• Study Start: 2006-09
• Primary Completion: 2010-06
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-23
• Last Update Posted: 2010-08-25
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• ACCP/SCCM sepsis criteria
• Need for institution of vasopressors after adequate volume resuscitation

Exclusion Criteria

• Age< 18
• On vasopressors for > 24 hours prior to ICU admission
• Other cause for shock ( cardiac tamponade, massive pulmonary embolus, cardiogenic shock)
• Physicians and family not committed to aggressive medical therapy ( a patient will not be excluded if he/she would receive all care except for attempts at resuscitation from cardiac arrest)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of vasopressor treatment	within 90 days

Secondary Outcome Measures

Name	Time	Method
Total number of vials vasopressors administered	Within 90 days
Time on more than single vasopressor	Within 90 days
Volume of intravenous fluids administered in first 7 days	7 days
Number of organ failures	Within 90 days
ICU mortality rates	Within 90 days

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States