N/A
Completed N=142
Preemptive Resuscitation for Eradication of Septic Shock
Sepsis · Severe Sepsis
Source: ClinicalTrials.gov NCT01449721 ↗
Enrolled (actual)
142
Serious AEs
4.9%
Results posted
Oct 2017
Primary outcomePrimary: Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1 — 34; 20 Participants — p=0.064
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1 |
34; 20 | 0.064 |
| SECONDARY In-hospital Mortality |
4; 0 | — |
| SECONDARY Number of Participants With Experiencing Complications Related to Intravascular Volume Overload |
4; 3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01449721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.