Sepsis, Severe Sepsis, Shock, Septic
Conditions
Keywords
Clinical trial, Controlled clinical trial, Shock, Septic
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).
Interventions
PROCEDUREFluid and Vasopressor Protocol
A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol
Sponsors
National Institute of General Medical Sciences (NIGMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of vasopressor treatment | within 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Total number of vials vasopressors administered | Within 90 days |
| Time on more than single vasopressor | Within 90 days |
| Volume of intravenous fluids administered in first 7 days | 7 days |
| Number of organ failures | Within 90 days |
| ICU mortality rates | Within 90 days |
Countries
United States
Contacts
Primary ContactJonathan E Sevransky, MD
Outcome results
None listed