NCT00335907

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

August 25, 2010

Status Verified

August 1, 2010

Enrollment Period

3.8 years

First QC Date

June 9, 2006

Last Update Submit

August 23, 2010

Conditions

Shock, SepticSevere SepsisSepsis

Keywords

Clinical trialControlled clinical trialShock, Septic

Outcome Measures

Primary Outcomes (1)

  • Length of vasopressor treatment

    within 90 days

Secondary Outcomes (5)

  • 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

Interventions

Fluid and Vasopressor ProtocolPROCEDURE

A Physician Ordered, Nurse Administered Fluid and Vasopressor Protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ACCP/SCCM sepsis criteria
  • Need for institution of vasopressors after adequate volume resuscitation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Jonathan E Sevransky, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan E Sevransky, MD

CONTACT

410-550-0546jsevran1@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 9, 2006

First Posted

June 12, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2010

Study Completion

January 1, 2011

Last Updated

August 25, 2010

Record last verified: 2010-08

Locations

US(1)