Recruiting

Vasopressors

Sponsor:

National Institute of General Medical Sciences (NIGMS)

Code:

NCT00335907

Conditions

Shock, Septic

Severe Sepsis

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluid and Vasopressor Protocol

Study Details

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.

Conditions

Shock, Septic

Severe Sepsis

Sepsis

Study ID

NCT00335907

Start date

Sep, 2006

Status verified date

Aug, 2010

Completion date

Jan, 2011

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Fluid and Vasopressor Protocol

A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol

Primary outcome measure

  • Length of vasopressor treatment [ Time Frame: within 90 days ]

Central Contacts and Locations

Central contacts

Jonathan E Sevransky, MD

410-550-0546jsevran1@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Principal Investigator:

Jonathan E Sevransky, MD

More Information

Sponsor

National Institute of General Medical Sciences (NIGMS)

Last update posted

Aug 25, 2010

Last verified

Aug, 2010

Keywords

  • Clinical trial
  • Controlled clinical trial
  • Shock, Septic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of General Medical Sciences (NIGMS) on 2010-08-25.