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Protocol-driven Hemodynamic Support for Patients With Septic Shock

Primary Purpose

Shock, Septic, Severe Sepsis, Sepsis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid and Vasopressor Protocol
Sponsored by
National Institute of General Medical Sciences (NIGMS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring Clinical trial, Controlled clinical trial, Shock, Septic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Johns Hopkins Bayview Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Length of vasopressor treatment

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2006
Last Updated
August 23, 2010
Sponsor
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00335907
Brief Title
Protocol-driven Hemodynamic Support for Patients With Septic Shock
Official Title
Protocol-driven Hemodynamic Support for Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of General Medical Sciences (NIGMS)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Septic, Severe Sepsis, Sepsis
Keywords
Clinical trial, Controlled clinical trial, Shock, Septic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Fluid and Vasopressor Protocol
Intervention Description
A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol
Primary Outcome Measure Information:
Title
Length of vasopressor treatment
Time Frame
within 90 days
Secondary Outcome Measure Information:
Title
Total number of vials vasopressors administered
Time Frame
Within 90 days
Title
Time on more than single vasopressor
Time Frame
Within 90 days
Title
Volume of intravenous fluids administered in first 7 days
Time Frame
7 days
Title
Number of organ failures
Time Frame
Within 90 days
Title
ICU mortality rates
Time Frame
Within 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan E Sevransky, MD
Phone
410-550-0546
Email
jsevran1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan E Sevransky, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan E Sevransky, MD

12. IPD Sharing Statement

Learn more about this trial

Protocol-driven Hemodynamic Support for Patients With Septic Shock

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