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Protocol-driven Hemodynamic Support for Patients With Septic Shock

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00335907
First received: June 9, 2006
Last updated: August 23, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention
Shock, Septic
Severe Sepsis
Sepsis
 Procedure: Fluid and Vasopressor Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protocol-driven Hemodynamic Support for Patients With Septic Shock

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • Length of vasopressor treatment [ Time Frame: within 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of vials vasopressors administered [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]
  • Time on more than single vasopressor [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]
  • Volume of intravenous fluids administered in first 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Number of organ failures [ Time Frame: Within 90 days ] [ Designated as safety issue: Yes ]
  • ICU mortality rates [ Time Frame: Within 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2006
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Fluid and Vasopressor Protocol
    A Physician Ordered, Nurse Administered 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335907

Contacts
Contact: Jonathan E Sevransky, MD 410-550-0546 jsevran1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Jonathan E Sevransky, MD            
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Jonathan E Sevransky, MD, MHS Johns Hopkins University
  More Information

No publications provided

Responsible Party: Jonathan Sevransky, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00335907     History of Changes
Other Study ID Numbers: K-23 NIGMS 2005
Study First Received: June 9, 2006
Last Updated: August 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Clinical trial
Controlled clinical trial
Shock, Septic

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2012