Preemptive Resuscitation for Eradication of Septic Shock

This study is currently recruiting participants.
Verified October 2013 by Christiana Care Health Services
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01449721
First received: September 29, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to assess the ability of an empiric resuscitation strategy compared to standard care to decrease the incidence of organ failure in normotensive sepsis patients.


Condition Intervention
Sepsis
Severe Sepsis
Drug: Intravenous fluid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preemptive Empiric Resuscitation Protocol for the Prevention of Disease Progression in the Treatment of Sepsis

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Organ failure [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Development of worsening organ failure (SOFA score increased by >1 point) over 72 hours.


Secondary Outcome Measures:
  • Mortality [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
    All-cause in-hospital mortality (up to 1 year).

  • Volume overload [ Time Frame: 12 hours following treatment initiation ] [ Designated as safety issue: Yes ]

    Composite safety endpoint:

    • Premature termination of the protocol-directed intravenous fluid administration by the investigator or primary physician due to presumed volume overload
    • Administration of intravenous diuretic for acute pulmonary edema
    • Respiratory failure requiring ventilatory assistance (BiPAP, CPAP, or mechanical ventilation) secondary to pulmonary edema per primary care team


Estimated Enrollment: 140
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standard medical care by the primary treatment team.
Experimental: Interventional arm
Protocolized empiric resuscitation.
Drug: Intravenous fluid
0.9% Sodium chloride intravenous fluid
Other Name: Normal saline

Detailed Description:

Sepsis is a challenging and elusive entity with a high mortality rate. As a syndrome, clinicians are challenged to distinguish individuals with systemic infection warranting further interventions from lower severity patients. Sepsis is now recognized as a time-sensitive emergency, as patients stand the best chance for survival when effective therapeutic interventions are delivered as early as possible.

Recent data has shown that in-hospital disease progression from sepsis to septic shock is associated with a higher risk of morbidity and mortality than those with shock on initial presentation. Yet, even when identified and treated with early aggressive interventions, the development of septic shock is still associated with a mortality rate of 25-40%.

Although the presence of sustained arterial hypotension or serum lactate elevation (>4.0 mmol/L) are the currently recommended threshold to define the presence of overt shock and the need for aggressive resuscitation, the investigators have shown that, in patients with systemic infection, a moderate lactate elevation (2.0-3.9 mmol/L) is a common occurrence and an important warning sign for the increased risk of disease progression and death. Sepsis with an elevated lactate between 2.0-3.9, referred to as the "PRE-SHOCK" state, identifies this population of patients at-risk for poor outcome. Current guidelines for sepsis management do not recommend any specific resuscitation measures or therapies for this at-risk population. This study marks the first in a series of investigations addressing the PRE-SHOCK population to further define the adverse events within this cohort and to investigate novel interventions to improve outcomes.

The investigators hypothesize that an early quantitative resuscitation strategy using a protocol-directed IV fluid resuscitation will result in a significant reduction in the development of worsening organ failure (including shock) and mortality compared to standard care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Emergency department patient with suspected or confirmed infection as primary reason for admission
  • Serum venous lactate 2.0 - 3.9 mmol/L
  • Hospital admission planned

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Serum lactate ≥ 4.0 mmol/L
  • Any vasopressor or inotrope requirement
  • Mechanical ventilation or non-invasive positive pressure ventilation
  • Chronic end-stage renal disease requiring hemodialysis
  • Pulmonary edema as diagnosed by the primary care team
  • Requirement for surgery within the treatment protocol timeframe
  • Inability to obtain informed consent from subject or surrogate
  • Patient to receive comfort measures only
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449721

Contacts
Contact: Ryan C Arnold, MD 302-304-1828 ryarnold@christianacare.org
Contact: Alan Jones, MD aejones@umc.edu

Locations
United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19718
Contact: Ryan Arnold, MD    302-304-1828    ryarnold@christianacare.org   
Contact: Debra Marco, RN    302-733-4130    DMarco@Christianacare.org   
Principal Investigator: Ryan C Arnold, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nathan I Shapiro, MD, MPH       nshapiro@bidmc.harvard.edu   
Principal Investigator: Nathan I Shapiro, MD, MPH         
United States, Michigan
Detroit Receiving Hospital/University Health Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Robert L Sherwin, MD       RSherwin@dmc.org   
Principal Investigator: Robert Sherwin, MD         
Sub-Investigator: James Paxton, MD, MBA         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Sarah Sterling    601-984-5782    sasterling@umc.edu   
Contact: Alan Jones, MD       aejones@umc.edu   
Sub-Investigator: Alan Jones, MD         
Principal Investigator: Sarah A Sterling, MD         
United States, New Jersey
Cooper University Hospital:Cooper Medical School of Rowan University Completed
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Study Chair: Alan Jones, MD University of Mississippi Medical Center
Principal Investigator: Ryan Arnold, MD Cooper University Hospital: Cooper Medical School of Rowan University
  More Information

Publications:
Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01449721     History of Changes
Other Study ID Numbers: PRESHOCK
Study First Received: September 29, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Sepsis
Multiple organ failure
Resuscitation

Additional relevant MeSH terms:
Sepsis
Toxemia
Disease Progression
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on April 16, 2014