Protocol-driven Hemodynamic Support for Patients With Septic Shock

Study Overview
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Brief Summary
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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
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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).

Official Title
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Protocol-driven Hemodynamic Support for Patients With Septic Shock

Conditions
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Shock, Septic, Severe Sepsis, Sepsis

Intervention / Treatment
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* Procedure: Fluid and Vasopressor Protocol


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Fluid and Vasopressor Protocol|A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of vasopressor treatment |  | within 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical trial, Controlled clinical trial, Shock, Septic