Protocol-driven Hemodynamic Support for Patients With Septic Shock

Sepsis Clinical Trial

Official title:

Protocol-driven Hemodynamic Support for Patients With Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00335907
• Other study ID #: K-23 NIGMS 2005
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2006
• Last updated: August 23, 2010
• Start date: September 2006
• Est. completion date: January 2011

Study information

• Verified date: August 2010
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: Jonathan E Sevransky, MD
• Phone: 410-550-0546
• Email: jsevran1[@]jhmi.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Shock
• Shock, Septic

Intervention

Procedure:
• Fluid and Vasopressor Protocol
A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of vasopressor treatment		within 90 days	No
Secondary	Total number of vials vasopressors administered		Within 90 days	No
Secondary	Time on more than single vasopressor		Within 90 days	No
Secondary	Volume of intravenous fluids administered in first 7 days		7 days	No
Secondary	Number of organ failures		Within 90 days	Yes
Secondary	ICU mortality rates		Within 90 days	No