Evidence map›Paper›PMID 24289512›Full record

Trial reportCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2013

Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.

Francis Pike, Donald M Yealy, John A Kellum, David T Huang, Amber E Barnato, Tammy L Eaton, Derek C Angus, Lisa A Weissfeld, ProCESS Investigators

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Critical care and resuscitation : journal of the Australasian Academy of Critical 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 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02030158 completednot on this mapstarted 2015, after this paper: background citation

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

TypeobservationalSponsorAustralian and New Zealand Intensive Care Research CentreRan2015 to 2016Enrolled4,210ConditionsSevere Sepsis and Septic Shock
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Medical journal, Armed Forces India
    Review
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.

Francis PikeDepartment of Biostatistics, Pitt Public Health, University of Pittsburgh, Pittsburgh, Pa, United States. lweis@pitt.edu.
Donald M Yealy
John A Kellum
David T Huang
Amber E Barnato
Tammy L Eaton
Derek C Angus
Lisa A Weissfeld
ProCESS Investigators

Funding

Protocolized Care for Early Septic Shock (ProCESS)P50GM076659 · NIGMS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ANGUS, DEREK C · 2006 to 2012
$11.2M
Pittsburgh Career Development Program in Emergency Medicine ResearchK12HL109068 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI CALLAWAY, CLIFTON W., YEALY, DONALD M · 2011 to 2015
$3.1M
NHLBI NIH HHS K12 HL109068NIGMS NIH HHS P50 GM076659
6 · The paper itself

Abstract

backgroundThe Protocolized Care for Early Septic Shock study is a randomised, multicentre, prospective, three-arm, parallel-group trial of alternative resuscitation strategies for early septic shock.

objectiveTo state our analysis plan for trial data.

methodsOur plan is to guide data collection and analysis using pre-existing definitions and testing, with local consensus-based efforts where needed. We examine protocolised care (two experimental approaches) and compare this to usual "wild type" care.

resultsOur plan is to address three aims (clinical efficacy, biology of illness and recovery, and costs and cost-effectiveness) and four hypotheses, and we specify rules for handling data and determining outcomes.

conclusionBy using measures to maintain study conduct and analysis rigour, we hope to improve understanding of early septic shock resuscitation and care of patients.

Indexed as

Clinical ProtocolsHospital MortalityResuscitationAcute Kidney InjuryCritical Care NursingData Interpretation, StatisticalHumansMulticenter Studies as TopicOutcome Assessment, Health CareProspective StudiesRenal Replacement TherapyShock, Septic

Identifiers

PMID24289512
PMCPMC4081520

What OpenQuestion holds

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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.