- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00335907
Protocol-driven Hemodynamic Support for Patients With Septic Shock
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan E Sevransky, MD
- Phone Number: 410-550-0546
- Email: jsevran1@jhmi.edu
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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
Time Frame: within 90 days
|
within 90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total number of vials vasopressors administered
Time Frame: Within 90 days
|
Within 90 days
|
Time on more than single vasopressor
Time Frame: Within 90 days
|
Within 90 days
|
Volume of intravenous fluids administered in first 7 days
Time Frame: 7 days
|
7 days
|
Number of organ failures
Time Frame: Within 90 days
|
Within 90 days
|
ICU mortality rates
Time Frame: Within 90 days
|
Within 90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jonathan E Sevransky, MD, MHS, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K-23 NIGMS 2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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