Protocol-driven Hemodynamic Support for Patients With Septic Shock

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Shock, Septic; Severe Sepsis
• Intervention / Treatment: Procedure: Fluid and Vasopressor Protocol

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Principal Investigator: Jonathan E Sevransky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of vasopressor treatment	within 90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Jonathan E Sevransky, MD, MHS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: June 9, 2006
• First Submitted That Met QC Criteria: June 9, 2006
• First Posted (Estimate): June 12, 2006

Study Record Updates

• Last Update Posted (Estimate): August 25, 2010
• Last Update Submitted That Met QC Criteria: August 23, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Clinical trial; Shock, Septic; Controlled clinical trial
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock; Vasoconstrictor Agents
• Other Study ID Numbers: K-23 NIGMS 2005