Evidence map›Paper›PMID 25928214›Full record

Trial reportCritical care (London, England)2015

Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial.

Pedro Póvoa, Jorge I F Salluh, Maria L Martinez, Raquel Guillamat-Prats, Dianne Gallup, Hussein R Al-Khalidi, B Taylor Thompson, V Marco Ranieri, Antonio Artigas

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT00604214 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

TypeinterventionalSponsorEli Lilly and CompanyRan2008 to 2012Enrolled1,696ConditionsSepsisArmsDrotrecogin alfa (activated), Placebo
NCT04593212 unknown statusnot on this mapstarted 2023, after this paper: background citation

Improving the Assessment of Microcirculatory Dysfunction in Septic Shock Patients Using Optical Coherence Tomography Angiography at the Bedside

TypeobservationalSponsorHospital da Luz, PortugalRan2023 to 2024Enrolled165ConditionsSeptic ShockArmsOptical Coherence Tomography Angiography
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. It's About Time ….Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2015
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 5 countries.

Pedro PóvoaPolyvalent Intensive Care Unit, São Francisco Xavier Hospital, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal. pedrorpovoa@gmail.com.
Jorge I F SalluhD'or Institute for Research and Education, Rio de Janeiro, Brazil. jorgesalluh@gmail.com.
Maria L MartinezCritical Care Center, Sabadell Hospital, Corporación Sanitaria Universitaria Parc Taulí, Universitat Autonoma de Barcelona, Sabadell, Spain. makilu80@hotmail.com.
Raquel Guillamat-PratsCritical Care Center, Sabadell Hospital, Corporación Sanitaria Universitaria Parc Taulí, Universitat Autonoma de Barcelona, Sabadell, Spain. rguillamat@tauli.cat.
Dianne GallupDuke Clinical Research Institute, Durham, NC, USA. dianne.gallup@duke.edu.
Hussein R Al-KhalidiDuke Clinical Research Institute, Durham, NC, USA. hussein.al-khalidi@duke.edu.
B Taylor ThompsonPulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Boston, USA. TTHOMPSON1@mgh.harvard.edu.
V Marco RanieriDipartimento di Anestesiologia e Rianimazione, Azienda Ospedaliera Città della Salute e della Scienza e di Torino_Molinette, Università di Torino, Torino, Italy. marco.ranieri@unito.it.
Antonio ArtigasCritical Care Center, Sabadell Hospital, Corporación Sanitaria Universitaria Parc Taulí, Universitat Autonoma de Barcelona, Sabadell, Spain. aartigas@tauli.cat.
Clinical Research Institute · USAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITCentro de Investigación Biomédica en Red de Enfermedades Respiratorias · ESDeleted InstitutionD’Or Institute for Research and Education · BRMassachusetts General Hospital · USUniversitat Autònoma de Barcelona · ESUniversity of Lisbon · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of our study was to evaluate the clinical impact of the administration of intravenous steroids, alone or in conjunction with drotrecogin-alfa (activated) (DrotAA), on the outcomes in septic shock patients.

methodsWe performed a sub-study of the PROWESS-Shock trial (septic shock patients who received fluids and vasopressors above a predefined threshold for at least 4 hours were randomized to receive either DrotAA or placebo for 96 hours). A propensity score for the administration of intravenous steroids for septic shock at baseline was constructed using multivariable logistic regression. Cox proportional hazards model using inverse probability of treatment weighting of the propensity score was used to estimate the effect of intravenous steroids, alone or in conjunction with DrotAA, on 28-day and 90-day all-cause mortality.

resultsA total of 1695 patients were enrolled of which 49.5% received intravenous steroids for treatment of septic shock at baseline (DrotAA + steroids N = 436; DrotAA + no steroids N = 414; placebo + steroids N = 403; placebo + no steroids N = 442). The propensity weighted risk of 28-day as well as 90-day mortality in those treated vs. those not treated with steroids did not differ among those randomized to DrotAA vs. placebo (interaction p-value = 0.38 and p = 0.27, respectively) nor was a difference detected within each randomized treatment. Similarly, the course of vasopressor use and cardiovascular SOFA did not appear to be influenced by steroid therapy. In patients with lung infection (N = 744), abdominal infection (N = 510), Gram-positive sepsis (N = 420) and Gram-negative sepsis (N = 461), the propensity weighted risk of 28-day as well as 90-day mortality in those treated vs. those not treated with steroids did not differ among those randomized to DrotAA vs. placebo nor was a difference detected within each randomized treatment.

conclusionsIn the present study of septic shock patients, after adjustment for treatment selection bias, we were unable to find noticeable positive impact from intravenous steroids for treatment of septic shock at baseline either in patients randomized for DrotAA or placebo.

trial registrationClinicaltrials.gov NCT00604214 . Registered 24 January 2008.

Indexed as

Administration, IntravenousAgedAnti-Infective AgentsFemaleHumansMaleMiddle AgedProtein CRecombinant ProteinsRetrospective StudiesShock, SepticSteroidsSurvival RateTreatment OutcomeAnti-Infective Agentsdrotrecogin alfa activatedProtein CRecombinant ProteinsSteroids

Identifiers

PMID25928214
PMCPMC4456711
OpenAlexW2163394915

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.