Evidence map›Paper›PMID 20179283›Full record

Trial reportJAMA2010

Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial.

Alan E Jones, Nathan I Shapiro, Stephen Trzeciak, Ryan C Arnold, Heather A Claremont, Jeffrey A Kline, Emergency Medicine Shock Research Network (EMShockNet) Investigators

10 registry-linked trialsOpen access · greenAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 388 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
388citing papers in PubMed, 17 pooled it
46.7field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00372502 nacompletednot on this map

Lactate Assessment in the Treatment of Early Sepsis: The LactATES Trial

TypeinterventionalSponsorNational Institute of General Medical Sciences (NIGMS)Ran2007 to 2008Enrolled300ConditionsSevere Sepsis, Septic ShockArmsModified EGDT, Standard EGDT
NCT01128413 naterminatednot on this map

Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)

TypeinterventionalSponsorWashington University School of MedicineRan2010 to 2013Enrolled22ConditionsShockArmsCheetah NICOM® PLRT, USCOM ® (Ultrasound Cardiac Output Monitor), Inferior Vena Cava (IVC) Ultrasound Collapsibility, CURVES Questionnaire, Lactate Clearance
NCT01709565 unknown statusnot on this mapstarted 2012, after this paper: background citation

Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction

TypeobservationalSponsorSamsung Medical CenterRan2012 to 2014Enrolled245ConditionsSepsis, Liver Failure
NCT02977429 naunknown statusnot on this mapstarted 2016, after this paper: background citation

Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer

TypeinterventionalSponsorTianjin Medical University Cancer Institute and HospitalRan2016 to 2018Enrolled150ConditionsAbdominal Tumor, Abdominal InfectionArmsstandardized fluid therapy, conventional fluid therapy
NCT03078712 nacompletednot on this mapstarted 2017, after this paper: background citation

Early Goal Directed Therapy Using a Physiological Holistic View. A Multicenter Study in Latin America: The ANDROMEDA-SHOCK Study

TypeinterventionalSponsorPontificia Universidad Catolica de ChileRan2017 to 2018Enrolled424ConditionsSeptic Shock, Hyperlactatemia, Peripheral PerfusionArmsPeripheral Perfusion guided resuscitation, Lactate guided resuscitation
NCT03137446 nacompletednot on this mapstarted 2017, after this paper: background citation

Assessing Targeted Fluid Resuscitation Strategies Among Patients With Severe Sepsis and Septic Shock

TypeinterventionalSponsorRhode Island HospitalRan2017 to 2018Enrolled113ConditionsSeptic Shock, Severe SepsisArmsIntravenous Fluid Cap
NCT03762005 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Peripheral Perfusion Versus Lactate Targeted Fluid Resuscitation in Septic Shock: ANDROMEDA-SHOCK PHYSIOLOGY STUDY

TypeinterventionalSponsorPontificia Universidad Catolica de ChileRan2018 to 2019Enrolled46ConditionsSeptic Shock, Hyperlactatemia, Peripheral PerfusionArmsCRT guided resuscitation, Lactate guided resuscitation
NCT04169412 completednot on this mapstarted 2019, after this paper: background citation

Resuscitation Failure, Protein Carbonyl and Receptor Interacting Protein Kinase 3 as Mortality Predictor in Septic Patient

Typeobservational_patient_registrySponsorUniversitas SriwijayaRan2019 to 2019Enrolled72ConditionsSepsisArmsBlood Collection
NCT04641104 phase4completednot on this mapstarted 2020, after this paper: background citation

The Thiamine Administration After Cardiac Surgery Trial

TypeinterventionalSponsorSarah SaxenaRan2020 to 2022Enrolled200ConditionsLactate Blood Increase, Thiamine DeficiencyArmsThiamine 500 MG, Placebo
NCT07179276 narecruitingnot on this mapstarted 2026, after this paper: background citation

Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock: A Multicenter Prospective Randomized Trial (CARBON)

TypeinterventionalSponsorUniversity Hospital, Clermont-FerrandRan2026 to 2027Enrolled750ConditionsSepsis - to Reduce Mortality in the Intensive Care Unit, Septic ShockArmsCO2gap-guided resuscitation strategy
3 · Its place in the literature

Who cites it

388 citing papers in PubMed, 17 syntheses or guidelines pooled it, 1,037 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020
    Guideline
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. The haemodynamic dilemma in emergency care: Is fluid responsiveness the answer? A systematic review.Scandinavian journal of trauma, resuscitation and emergency medicine · 2017
    Pooled it
  14. Guideline
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Trial
  19. Trial
  20. Trial

328 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Alan E JonesDepartment of Emergency Medicine, 1000 Blythe Blvd, Carolinas Medical Center, Charlotte, NC 28203, USA.
Nathan I Shapiro
Stephen Trzeciak
Ryan C Arnold
Heather A Claremont
Jeffrey A Kline
Emergency Medicine Shock Research Network (EMShockNet) Investigators
Carolinas Medical Center · US

Funding

Protocolized Care for Early Septic Shock (ProCESS)P50GM076659 · NIGMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ANGUS, DEREK C · 2006 to 2012
$11.2M
Endothelial Cell Signaling and Microcirculatory Flow in Severe SepsisR01HL091757 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SHAPIRO, NATHAN I · 2008 to 2011
$2.0M
Randomized Clinical Trial of a Less-Invasive Resuscitation Protocol for SepsisK23GM076652 · NIGMS · CAROLINAS MEDICAL CENTER · PI JONES, ALAN E · 2006 to 2010
$699k
Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in SepsisK23GM083211 · NIGMS · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI TRZECIAK, STEPHEN WALTER · 2008 to 2012
$679k
NHLBI NIH HHS HL091757NHLBI NIH HHS R01 HL091757NIGMS NIH HHS GM076659NIGMS NIH HHS GM76652NIGMS NIH HHS GM83211NIGMS NIH HHS K23 GM076652NIGMS NIH HHS K23 GM083211NIGMS NIH HHS P50 GM076659
6 · The paper itself

Abstract

contextGoal-directed resuscitation for severe sepsis and septic shock has been reported to reduce mortality when applied in the emergency department.

objectiveTo test the hypothesis of noninferiority between lactate clearance and central venous oxygen saturation (ScvO2) as goals of early sepsis resuscitation. DESIGN, SETTING, AND PATIENTS: Multicenter randomized, noninferiority trial involving patients with severe sepsis and evidence of hypoperfusion or septic shock who were admitted to the emergency department from January 2007 to January 2009 at 1 of 3 participating US urban hospitals.

interventionsWe randomly assigned patients to 1 of 2 resuscitation protocols. The ScvO2 group was resuscitated to normalize central venous pressure, mean arterial pressure, and ScvO2 of at least 70%; and the lactate clearance group was resuscitated to normalize central venous pressure, mean arterial pressure, and lactate clearance of at least 10%. The study protocol was continued until all goals were achieved or for up to 6 hours. Clinicians who subsequently assumed the care of the patients were blinded to the treatment assignment.

main outcome measureThe primary outcome was absolute in-hospital mortality rate; the noninferiority threshold was set at Delta equal to -10%.

resultsOf the 300 patients enrolled, 150 were assigned to each group and patients were well matched by demographic, comorbidities, and physiological features. There were no differences in treatments administered during the initial 72 hours of hospitalization. Thirty-four patients (23%) in the ScvO2 group died while in the hospital (95% confidence interval [CI], 17%-30%) compared with 25 (17%; 95% CI, 11%-24%) in the lactate clearance group. This observed difference between mortality rates did not reach the predefined -10% threshold (intent-to-treat analysis: 95% CI for the 6% difference, -3% to 15%). There were no differences in treatment-related adverse events between the groups.

conclusionAmong patients with septic shock who were treated to normalize central venous and mean arterial pressure, additional management to normalize lactate clearance compared with management to normalize ScvO2 did not result in significantly different in-hospital mortality.

trial registrationclinicaltrials.gov Identifier: NCT00372502.

Indexed as

Fluid TherapyAdultAgedCardiotonic AgentsCentral Venous PressureDobutamineErythrocyte TransfusionFemaleHospital MortalityHumansLactic AcidMaleMiddle AgedOxygenProspective StudiesSepsisCardiotonic AgentsDobutamineLactic AcidOxygenVasoconstrictor Agents

Identifiers

PMID20179283
PMCPMC2918907
OpenAlexW2130075376

What OpenQuestion holds

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Registered trials

and 4 more above

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.