Trial reportThe New England journal of medicine2001
Early goal-directed therapy in the treatment of severe sepsis and septic shock.
Trial report in The New England journal of medicine, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 38 registered trials, which are not on this map. Cited by 2,760 papers, 10 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Plasma Protein Biomarker Based Diagnostics of Outcome in Sepsis & CAP
Early Lactate-Directed Therapy on the ICU: A Randomized Controlled Trial
Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients: BaSES (130;0.4) Trial
An Outcomes Comparison of ACCM/PALS Guidelines For Pediatric Septic Shock With and Without Central Venous Oxygen Saturation Monitoring
Safety and Efficacy of Restricted Fluid Regimen in Open Abdominal Bowel Surgery
Protocolized Care for Early Septic Shock
A Multi-center Randomized Comparison of a Minimally-invasive Cardiovascular Hemodynamic Optimization (MiCHO) Protocol Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock Patients Presenting to the Emergency Department
Randomized Double-blind Placebo-controlled Trial of Inhaled Nitric Oxide for the Treatment of Microcirculatory Dysfunction and Organ Failure in Sepsis
Hemodynamics and Extravascular Lung Water in Acute Lung Injury: A Prospective Randomized Controlled Multicentered Trial of Goal Directed Treatment of EVLW Versus Standard Management for the Treatment of Acute Lung Injury
Evaluation of Corticosteroid Therapy in Childhood Severe Sepsis (Steroids in Paediatric Sepsis, StePS) - a Randomised Pilot Study
Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)
Reducing Elevated Heart Rate in Patients With Multiple Organ Dysfunction Syndrome (MODS) by the "Funny Channel" Current (If) Inhibitor Ivabradine
Critical Care Excellence in Sepsis and Trauma
Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit
Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction
Statistical Analysis Plan for an Individual Patient Data Meta-analysis of Three, International, Multicentre, Randomised, Controlled Trials Comparing Protocolised With Usual Resuscitation in Patients Presenting to the Emergency Department With Severe Sepsis and Septic Shock
Evaluating Agreement Between USCOM and 2D-echocardiographic Hemodynamic Measurements in Pediatric Patients
Measurement of Oxygen Consumption in Critical Illness Using Optical Gas Analysis
Automated Pulse Pressure Variation Guided Fluid Management in the Pediatric Intensive Care Setting
Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock
Fluid Balance in the ICU - Interventions to Minimize Fluids in Patients With Septic Shock
Description of Fluid Balance in Patients With Acute Respiratory Failure
Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status During Lower Body Negative Pressure Simulation
Does Intravenous Lactated Ringer Solution Raise Measured Serum Lactate?
The Critical Care Ultrasound Based Characteristic of Hemodynamic and Lung Pathology in Early Stage of Shock in ICU: The Epidemic and Prognostic Value
Assessing Targeted Fluid Resuscitation Strategies Among Patients With Severe Sepsis and Septic Shock
Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
Extension of the Rapid Ultrasound for Shock and Hypotension to Evaluate Volume Responsiveness
Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock: A Multicenter, Stepped Wedge Cluster Randomized Trial
Mortality Due to Septic Shock Associated With Thrombocytopenia in the Intensive Care Unit
Impact on Lactate Clearance of Early Hemodynamic Optimization Through Pleth Variability Index in the ED for Resuscitated Out-of-hospital Cardiac Arrests
EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock
Assessment Of Volume Responsiveness By Ultrasound Parameters Of Carotid Blood Flow In Patients With Cardiogenic Shock
Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children
Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Adults With Sepsis: A Feasibility Study for a Multicenter Double-Blind Randomized Placebo-Controlled Trial
Assessment of Intra-thoracic Water by Bio Reactance During Stabilization and Therapeutic De-escalation in Septic Shock: A Prospective, Multicenter, Observational Study
Efficacy and Safety of Balanced Gelatin Solution for Fluid Infusion in Sepsis Patients Undergoing Emergency Abdominal Surgery: A Multicenter, Adaptive Designed, Randomized Controlled Trial
Efficacy, Safety, and Tolerability of Methylprednisolone in Critically Ill Patients With the Hyperinflammatory Phenotype: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial
Who cites it
2,760 citing papers in PubMed, 10 syntheses or guidelines pooled it, 10,728 citations in OpenAlex.
- Surviving Sepsis Campaign International Guidelines for the Management of Sepsis and Septic Shock in Children 2026.Intensive care medicine · 2026Pooled it
- Sepsis mortality prediction using machine learning and deep learning - a systematic review.BMC medical informatics and decision making · 2025Pooled it
- [S3 guideline on sepsis-prevention, diagnosis, therapy, and follow-up care-update 2025].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2025Guideline
- ESICM guidelines on circulatory shock and hemodynamic monitoring 2025.Intensive care medicine · 2025Guideline
- Is age associated with different vital signs in adults presenting to hospital with bacterial infection? A systematic review and meta-analysis.Age and ageing · 2025Pooled it
- The association of pulmonary artery catheterization utilization and surgical patients' outcomes: a PRISMA-compliant systematic review and meta-analysis.Journal of cardiothoracic surgery · 2025Pooled it
- The Diagnostic Utility of Host RNA Biosignatures in Adult Patients With Sepsis: A Systematic Review and Meta-Analysis.Critical care explorations · 2025Pooled it
- Classical formula Taohe Chengqi decoction as an adjuvant therapy for sepsis - a systematic review and meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2025Pooled it
- The impact of telehealth in sepsis care: A systematic review.Journal of telemedicine and telecare · 2025Pooled it
- Early management of adult sepsis and septic shock: Korean clinical practice guidelines.Acute and critical care · 2024Guideline
- Early red blood cell transfusion strategy in septic shock among patients with cancer: the TRANSPORT randomized controlled trial.Intensive care medicine · 2026Trial
- Impact of renal vein doppler ultrasound-guided CVP titration in sepsis: a pilot randomized controlled trial.Critical care (London, England) · 2026Trial
- Restrictive fluid management with early de-escalation versus usual care in critically ill patients (reduce trial): a feasibility randomized controlled trial.Critical care (London, England) · 2025Trial
- Trial
- Heterogeneity in the Effect of Early Goal-Directed Therapy for Septic Shock: A Secondary Analysis of Two Multicenter International Trials.Critical care medicine · 2025Trial
- Influence of liberal versus conservative oxygen therapies on the hemodynamic parameters of mechanically ventilated patients with sepsis: a randomized clinical trial.BMC anesthesiology · 2024Trial
- Ringer's lactate administered at 15 °C leads to a greater and more prolonged increase in blood pressure compared to 37 °C.Scientific reports · 2024Trial
- Effect of the 1-h bundle on mortality in patients with suspected sepsis in the emergency department: a stepped wedge cluster randomized clinical trial.Intensive care medicine · 2024Trial
- Esophageal resonance Raman spectroscopy tracks mixed venous oxygenation in experimental shock and hypoxemia.Intensive care medicine experimental · 2026Article
- Decades of intensive care medicine trials: what randomised evidence has changed, corrected, and still questions to resolve.Intensive care medicine · 2026Review
2,700 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundGoal-directed therapy has been used for severe sepsis and septic shock in the intensive care unit. This approach involves adjustments of cardiac preload, afterload, and contractility to balance oxygen delivery with oxygen demand. The purpose of this study was to evaluate the efficacy of early goal-directed therapy before admission to the intensive care unit.
methodsWe randomly assigned patients who arrived at an urban emergency department with severe sepsis or septic shock to receive either six hours of early goal-directed therapy or standard therapy (as a control) before admission to the intensive care unit. Clinicians who subsequently assumed the care of the patients were blinded to the treatment assignment. In-hospital mortality (the primary efficacy outcome), end points with respect to resuscitation, and Acute Physiology and Chronic Health Evaluation (APACHE II) scores were obtained serially for 72 hours and compared between the study groups.
resultsOf the 263 enrolled patients, 130 were randomly assigned to early goal-directed therapy and 133 to standard therapy; there were no significant differences between the groups with respect to base-line characteristics. In-hospital mortality was 30.5 percent in the group assigned to early goal-directed therapy, as compared with 46.5 percent in the group assigned to standard therapy (P = 0.009). During the interval from 7 to 72 hours, the patients assigned to early goal-directed therapy had a significantly higher mean (+/-SD) central venous oxygen saturation (70.4+/-10.7 percent vs. 65.3+/-11.4 percent), a lower lactate concentration (3.0+/-4.4 vs. 3.9+/-4.4 mmol per liter), a lower base deficit (2.0+/-6.6 vs. 5.1+/-6.7 mmol per liter), and a higher pH (7.40+/-0.12 vs. 7.36+/-0.12) than the patients assigned to standard therapy (P < or = 0.02 for all comparisons). During the same period, mean APACHE II scores were significantly lower, indicating less severe organ dysfunction, in the patients assigned to early goal-directed therapy than in those assigned to standard therapy (13.0+/-6.3 vs. 15.9+/-6.4, P < 0.001).
conclusionsEarly goal-directed therapy provides significant benefits with respect to outcome in patients with severe sepsis and septic shock.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.