Protocol-driven Hemodynamic Support for Patients With Septic Shock

NCT ID: NCT00335907

Last Updated: 2010-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-01-31

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).

Conditions

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Shock, Septic Severe Sepsis Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fluid and Vasopressor Protocol

A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role lead

Responsible Party

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Johns Hopkins University

Principal Investigators

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Jonathan E Sevransky, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan E Sevransky, MD

Role: CONTACT

410-550-0546

Other Identifiers

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K-23 NIGMS 2005

Identifier Type: -

Identifier Source: org_study_id

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