Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial
ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated wit...
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| Veröffentlicht in: | Revista Brasileira de terapia intensiva 2018, Vol.30 (3), p.253-263 |
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| creator | Hernández, Glenn Cavalcanti, Alexandre Biasi Ospina-Tascón, Gustavo Dubin, Arnaldo Hurtado, Francisco Javier Damiani, Lucas Petri Friedman, Gilberto Castro, Ricardo Alegría, Leyla Cecconi, Maurizio Teboul, Jean-Louis Bakker, Jan |
| description | ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality.
To report the statistical analysis plan for the ANDROMEDA-SHOCK trial.
We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.
According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results. |
| doi_str_mv | 10.5935/0103-507X.20180041 |
| format | Article |
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To report the statistical analysis plan for the ANDROMEDA-SHOCK trial.
We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.
According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.</description><identifier>ISSN: 0103-507X</identifier><identifier>EISSN: 1982-4335</identifier><identifier>DOI: 10.5935/0103-507X.20180041</identifier><identifier>PMID: 30066731</identifier><language>eng ; por</language><publisher>Brazil: Associação de Medicina Intensiva Brasileira - AMIB</publisher><subject>Data Interpretation, Statistical ; Early Goal-Directed Therapy - methods ; Humans ; Lactic Acid - blood ; Life Sciences ; Original ; Research Design ; Resuscitation - methods ; Shock, Septic - therapy</subject><ispartof>Revista Brasileira de terapia intensiva, 2018, Vol.30 (3), p.253-263</ispartof><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6180476/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6180476/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,4026,27930,27931,27932,53798,53800</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30066731$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04534645$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Hernández, Glenn</creatorcontrib><creatorcontrib>Cavalcanti, Alexandre Biasi</creatorcontrib><creatorcontrib>Ospina-Tascón, Gustavo</creatorcontrib><creatorcontrib>Dubin, Arnaldo</creatorcontrib><creatorcontrib>Hurtado, Francisco Javier</creatorcontrib><creatorcontrib>Damiani, Lucas Petri</creatorcontrib><creatorcontrib>Friedman, Gilberto</creatorcontrib><creatorcontrib>Castro, Ricardo</creatorcontrib><creatorcontrib>Alegría, Leyla</creatorcontrib><creatorcontrib>Cecconi, Maurizio</creatorcontrib><creatorcontrib>Teboul, Jean-Louis</creatorcontrib><creatorcontrib>Bakker, Jan</creatorcontrib><title>Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial</title><title>Revista Brasileira de terapia intensiva</title><addtitle>Rev Bras Ter Intensiva</addtitle><description>ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality.
To report the statistical analysis plan for the ANDROMEDA-SHOCK trial.
We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.
According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.</description><subject>Data Interpretation, Statistical</subject><subject>Early Goal-Directed Therapy - methods</subject><subject>Humans</subject><subject>Lactic Acid - blood</subject><subject>Life Sciences</subject><subject>Original</subject><subject>Research Design</subject><subject>Resuscitation - methods</subject><subject>Shock, Septic - therapy</subject><issn>0103-507X</issn><issn>1982-4335</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkV1v0zAUhi0EYmXwB7hAvuUim78SJ1wgVd1YER2VGEjcWSe20xi5cWRnReVn7BcvWVnFuLJlv8-jo_Mi9JaSs7zi-TmhhGc5kT_PGKElIYI-QzNalSwTnOfP0ewYOEGvUvpFSEFoUbxEJ3y8FpLTGbq7GWBwaXAaPIYO_D65hHsPHW5CxBai3-NNAJ8ZF60erMFDayP0e3ybXLfBgPt2ZIIPmwdHG_yDDu-c_Y2zKY3nXy--ra8vL-bZzXK9-PJhhCJ0Jmzdn9GnQzfE4P2kjg78a_SiAZ_sm7_nKfrx6fL7Ypmt1lefF_NVpjlhNCsbYhuouWlYVZdcG0Z0zSQpQdSVEULa3MiSAiuphFzXoi4qk7PaVo1mjZT8FH08ePvbemuNtuMY4FUf3RbiXgVw6ulP51q1CTtVjMsWshgF7w-C9j9sOV-p6Y2InItC5Ds6Ztkhq2NIKdrmCFCipjbVVJaaylKPbY7Qu38nPCKP9fF7XxKdUw</recordid><startdate>2018</startdate><enddate>2018</enddate><creator>Hernández, Glenn</creator><creator>Cavalcanti, Alexandre Biasi</creator><creator>Ospina-Tascón, Gustavo</creator><creator>Dubin, Arnaldo</creator><creator>Hurtado, Francisco Javier</creator><creator>Damiani, Lucas Petri</creator><creator>Friedman, Gilberto</creator><creator>Castro, Ricardo</creator><creator>Alegría, Leyla</creator><creator>Cecconi, Maurizio</creator><creator>Teboul, Jean-Louis</creator><creator>Bakker, Jan</creator><general>Associação de Medicina Intensiva Brasileira - AMIB</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>1XC</scope><scope>5PM</scope></search><sort><creationdate>2018</creationdate><title>Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial</title><author>Hernández, Glenn ; 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To report the statistical analysis plan for the ANDROMEDA-SHOCK trial.
We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.
According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.</abstract><cop>Brazil</cop><pub>Associação de Medicina Intensiva Brasileira - AMIB</pub><pmid>30066731</pmid><doi>10.5935/0103-507X.20180041</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; PubMed Central |
| subjects | Data Interpretation, Statistical Early Goal-Directed Therapy - methods Humans Lactic Acid - blood Life Sciences Original Research Design Resuscitation - methods Shock, Septic - therapy |
| title | Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial |
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