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Protocol-driven Hemodynamic Support for Patients With Septic Shock

N

National Institute of General Medical Sciences (NIGMS)

Status

Unknown

Conditions

Shock, Septic
Severe Sepsis
Sepsis

Treatments

Procedure: Fluid and Vasopressor Protocol

Study type

Interventional

Funder types

NIH

Identifiers

NCT00335907
K-23 NIGMS 2005

Details and patient eligibility

About

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.

Full 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).

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Jonathan E Sevransky, MD

Data sourced from clinicaltrials.gov

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