ArticleIntensive care medicine2013
Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe.
Article in Intensive care medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02030158 (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), which is not on this map. Cited by 17 papers, 1 of them a synthesis 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.
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
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.
- The effect of goal-directed therapy on mortality in patients with sepsis - earlier is better: a meta-analysis of randomized controlled trials.Critical care (London, England) · 2014Pooled it
- Diagnostic and prognostic utility of soluble CD 14 subtype (presepsin) for severe sepsis and septic shock during the first week of intensive care treatment.Critical care (London, England) · 2014Trial
- A randomized trial of protocol-based care for early septic shock.The New England journal of medicine · 2014Trial
- Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2013Trial
- The intensive care medicine research agenda on septic shock.Intensive care medicine · 2017Review
- Much Ado About the New Definitions of Sepsis.Journal of critical care medicine (Universitatea de Medicina si Farmacie din Targu-Mures) · 2016Article
- Application of a Framework to Assess the Usefulness of Alternative Sepsis Criteria.Critical care medicine · 2016Article
- Early goal-directed resuscitation of patients with septic shock: current evidence and future directions.Critical care (London, England) · 2015Review
- Review
- Epidemiology and outcomes in patients with severe sepsis admitted to the hospital wards.Journal of critical care · 2015Observational
- [Early goal directed therapy in severe sepsis].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2014Review
- Prehospital intravenous access and fluid resuscitation in severe sepsis: an observational cohort study.Critical care (London, England) · 2014Observational
- Conservative fluid therapy in septic shock: an example of targeted therapeutic minimization.Critical care (London, England) · 2014Review
- Did they just prove that a diagnosis of "septic shock" is meaningless?American journal of respiratory and critical care medicine · 2014Article
- Year in review in Intensive Care Medicine 2013: III. Sepsis, infections, respiratory diseases, pediatrics.Intensive care medicine · 2014Article
- Critical care medicine 2013: a review and prospect.Journal of thoracic disease · 2013Review
- The new trials of early goal-directed resuscitation: three-part harmony or disharmony?Intensive care medicine · 2013Article
Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
purposeTo describe and compare the design of three independent but collaborating multicenter trials of early goal-directed resuscitation for severe sepsis and septic shock.
methodsWe reviewed the three current trials, one each in the USA (ProCESS: protocolized care for early septic shock), Australasia (ARISE: Australasian resuscitation in sepsis evaluation), and the UK (ProMISe: protocolised management in sepsis). We used the 2010 CONSORT (consolidated standards of reporting trials) statement and the 2008 CONSORT extension for trials assessing non-pharmacologic treatments to describe and compare the underlying rationale, commonalities, and differences.
resultsAll three trials conform to CONSORT guidelines, address the same fundamental questions, and share key design elements. Each trial is a patient-level, equal-randomized, parallel-group superiority trial that seeks to enroll emergency department patients with inclusion criteria that are consistent with the original early goal-directed therapy (EGDT) trial (suspected or confirmed infection, two or more systemic inflammatory response syndrome criteria, and refractory hypotension or elevated lactate), is powered to detect a 6–8 % absolute mortality reduction (hospital or 90-day), and uses trained teams to deliver EGDT. Design differences appear to primarily be driven by between-country variation in health care context. The main difference between the trials is the inclusion of a third, alternative resuscitation strategy arm in ProCESS.
conclusionsHarmonization of study design and methods between severe sepsis trials is feasible and may facilitate pooling of data on completion of the trials.
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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.