Preemptive Resuscitation for Eradication of Septic Shock

NCT01449721 | Completed Results

• 1 other identifier: PRESHOCK
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Sepsis; Severe Sepsis

Keywords

Sepsis; Multiple organ failure; Resuscitation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1

  Development of worsening organ failure defined by the Sequential Organ Failure Assessment (SOFA) score. The SOFA score defines the presence and severity of dysfunction within 6 organ systems (cardiovascular, respiratory, coagulation, liver, renal, and nervous system) with a value of "0" for assigned to normal function to a maximum value of "4" for severe dysfunction in each of the organ systems. Each component of the SOFA score is added together, ranging from "0" indicating no organ dysfunction in any of the 6 organ systems, to "24" indicating maximal organ dysfunction across all 6 organ systems. Within this trial, the occurrence of organ failure was defined by any increase in the total SOFA score by ≥ 1 point over the first 72 hours after randomization.

  72 hours

Secondary Outcomes (2)

• In-hospital Mortality

  In-hospital discharge or up to maximum 30 days

• Number of Participants With Experiencing Complications Related to Intravascular Volume Overload

  12 hours following treatment initiation

Study Arms (2)

Control

NO INTERVENTION

Standard medical care by the primary treatment team.

Interventional arm

EXPERIMENTAL

Protocolized empiric resuscitation delivering weight-based intravenous fluid resuscitation targeting lactate normalization

Drug: Intravenous fluid

Interventions

Intravenous fluid DRUG

0.9% Sodium chloride intravenous fluid

Also known as: Normal saline

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (5)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Detroit Receiving Hospital/University Health Center

Detroit, Michigan, 48201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cooper University Hospital:Cooper Medical School of Rowan University

Camden, New Jersey, 08103, United States

Location

Related Publications (3)

• Sakr Y, Vincent JL, Schuerholz T, Filipescu D, Romain A, Hjelmqvist H, Reinhart K. Early- versus late-onset shock in European intensive care units. Shock. 2007 Dec;28(6):636-643.

  PMID: 18092378 BACKGROUND

• Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.

  PMID: 19325467 BACKGROUND

• Glickman SW, Cairns CB, Otero RM, Woods CW, Tsalik EL, Langley RJ, van Velkinburgh JC, Park LP, Glickman LT, Fowler VG Jr, Kingsmore SF, Rivers EP. Disease progression in hemodynamically stable patients presenting to the emergency department with sepsis. Acad Emerg Med. 2010 Apr;17(4):383-90. doi: 10.1111/j.1553-2712.2010.00664.x.

  PMID: 20370777 BACKGROUND

MeSH Terms

Conditions

Sepsis; Multiple Organ Failure

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Ryan Arnold, MD, Director of Research, Emergency Medicine
• Organization: Christiana Care Health System

ryarnold@christianacare.org

302-733-5108

Study Officials

• Alan Jones, MD

  University of Mississippi Medical Center

  STUDY CHAIR

• Ryan Arnold, MD

  Cooper University Hospital: Cooper Medical School of Rowan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 10, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 4, 2017
• Results First Posted: October 4, 2017

Record last verified: 2017-10

Locations

US (5)