article196

Rivers Trial

"Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock". The New England Journal of Medicine. 2001. 345(19):1368-1377. PubMed • Full text • PDF

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9 Criticisms
10 Funding
11 Further Reading

Clinical Question

Does early goal-directed therapy before admission to the intensive care unit improve the outcomes of patients with severe sepsis and septic shock?

Bottom Line

Early goal-directed therapy in patients with severe sepsis and septic shock reduced in-hospital mortality compared to standard therapy.

Major Points

Early goal-directed therapy aims to optimize cardiac preload, afterload, and contractility to balance oxygen delivery with oxygen demand. This study assessed the efficacy of implementing early goal-directed therapy before admission to the intensive care unit (ICU) in patients with severe sepsis or septic shock.

Guidelines

Current guidelines recommend early goal-directed therapy as part of the initial management for severe sepsis and septic shock.

Design

- Prospective, randomized, controlled trial
- N=263 patients with severe sepsis or septic shock
- Early goal-directed therapy (n=130) vs. Standard therapy (n=133)
- Setting: Urban emergency department
- Enrollment: March 1997 to March 2000

Population

Inclusion Criteria
- Adults with severe sepsis, septic shock, or sepsis syndrome presenting to the emergency department
- Two of four criteria for systemic inflammatory response syndrome met
- Systolic blood pressure ≤90 mm Hg or blood lactate concentration ≥4 mmol per liter

Exclusion Criteria
- Age <18, pregnancy, acute cerebral vascular event, acute coronary syndrome, immediate surgical requirement, and other specific conditions

Baseline Characteristics
- No significant differences between the two groups

Interventions

- Early goal-directed therapy or standard therapy conducted for at least six hours pre-ICU
- Central venous catheter capable of measuring central venous oxygen saturation was used for early goal-directed therapy
- Standard therapy group received critical-care consultation and care based on clinician discretion

Outcomes

Primary Outcome
- In-hospital mortality: 30.5% in early goal-directed therapy vs. 46.5% in standard therapy (P=0.009)

Secondary Outcomes
- Early goal-directed therapy group had higher central venous oxygen saturation, lower lactate concentration, lower base deficit, and higher pH than standard therapy group (P≤0.02 for all)
- Lower mean APACHE II scores, indicating less severe organ dysfunction, in early goal-directed therapy group (P<0.001)

Criticisms

- The trial may have inherent bias from the influence of investigators on the care provided to the early goal-directed therapy group

Funding

- Funded by Henry Ford Health Systems Fund for Research, a Weatherby Healthcare Resuscitation Fellowship, equipment from Edwards Lifesciences, and laboratory assays equipment from Nova Biomedical