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Preemptive Resuscitation for Eradication of Septic Shock

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ClinicalTrials.gov Identifier: NCT01449721
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sepsis
Severe Sepsis
Intervention Drug: Intravenous fluid
Enrollment 142
Recruitment Details  
Pre-assignment Details Prior to interventional arm of the trial, a 5-month observational period was performed identifying 94 patients in the control arm. At the initiation of the interventional study, subjects were randomized in a 2:1 ratio to intervention:control, enrolling an additional 18 patients to the control arm, and 30 patients to the intervention.
Arm/Group Title Control Interventional Arm
Hide Arm/Group Description Standard medical care by the primary treatment team.

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

Intravenous fluid: 0.9% Sodium chloride intravenous fluid

Period Title: Overall Study
Started 112 30
Completed 112 28
Not Completed 0 2
Reason Not Completed
Physician Decision             0             1
Physician Decision             0             1
Arm/Group Title Control Interventional Arm Total
Hide Arm/Group Description Standard medical care by the primary treatment team.

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

Intravenous fluid: 0.9% Sodium chloride intravenous fluid

Total of all reporting groups
Overall Number of Baseline Participants 112 30 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 30 participants 142 participants
58.3  (15) 56.8  (16) 58  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 30 participants 142 participants
Female
51
  45.5%
12
  40.0%
63
  44.4%
Male
61
  54.5%
18
  60.0%
79
  55.6%
1.Primary Outcome
Title Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1
Hide Description

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.

Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Interventional Arm
Hide Arm/Group Description:
Standard medical care by the primary treatment team.

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

Intravenous fluid: 0.9% Sodium chloride intravenous fluid

Overall Number of Participants Analyzed 112 30
Measure Type: Count of Participants
Unit of Measure: Participants
34
  30.4%
20
  66.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Interventional Arm
Comments Null hypothesis: In patients with moderate severity sepsis, there is no change in the incidence of organ dysfunction within 72 hours associated with the use of an empiric fluid resuscitation algorithm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.064
Comments [Not Specified]
Method 2-sample z-test
Comments z-test for differences in proportions
2.Secondary Outcome
Title In-hospital Mortality
Hide Description Any occurrence of mortality while the participant is in-hospital is counted as an outcome.
Time Frame In-hospital discharge or up to maximum 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Interventional Arm
Hide Arm/Group Description:
Standard medical care by the primary treatment team.

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

Intravenous fluid: 0.9% Sodium chloride intravenous fluid

Overall Number of Participants Analyzed 112 30
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.6%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Experiencing Complications Related to Intravascular Volume Overload
Hide Description

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
Time Frame 12 hours following treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Interventional Arm
Hide Arm/Group Description:
Standard medical care by the primary treatment team.

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

Intravenous fluid: 0.9% Sodium chloride intravenous fluid

Overall Number of Participants Analyzed 112 30
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.6%
3
  10.0%
Time Frame Respiratory failure occurring within 24 hours of enrollment. Fluid overload occurring within 24 hours of enrollment. Mortality occurring at anytime within hospital stay.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Interventional Arm
Hide Arm/Group Description Standard medical care by the primary treatment team.

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

Intravenous fluid: 0.9% Sodium chloride intravenous fluid

All-Cause Mortality
Control Interventional Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   4/112 (3.57%)      0/30 (0.00%)    
Hide Serious Adverse Events
Control Interventional Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/112 (3.57%)      3/30 (10.00%)    
General disorders     
Mortality  [1]  4/112 (3.57%)  4 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory failure requiring mechanical intervention  [2]  4/112 (3.57%)  4 2/30 (6.67%)  2
Vascular disorders     
Intravascular fluid overload  [3]  0/112 (0.00%)  0 2/30 (6.67%)  2
Indicates events were collected by systematic assessment
[1]
All cause in-hospital mortality
[2]
Any mechanical ventilation within 24 hours of enrollment.
[3]
Assessment by treating physician of intravascular fluid overload
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Interventional Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/30 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ryan Arnold, MD, Director of Research, Emergency Medicine
Organization: Christiana Care Health System
Phone: 302-733-5108
EMail: ryarnold@christianacare.org
Layout table for additonal information
Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01449721    
Other Study ID Numbers: PRESHOCK
First Submitted: September 29, 2011
First Posted: October 10, 2011
Results First Submitted: November 30, 2016
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017