Protocolized Care for Early Septic Shock (ProCESS) Statistical Analysis Plan

Overview

Journal Crit Care Resusc

Specialties Anesthesiology
Critical Care

Date 2013 Dec 3

PMID 24289512

Citations 6

Authors

Francis Pike

Donald M Yealy

John A Kellum

David T Huang

Amber E Barnato

Tammy L Eaton

Derek C Angus

Lisa A Weissfeld

Affiliations

Soon will be listed here.

Abstract

Background: The 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.

Objective: To state our analysis plan for trial data.

Methods: Our 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.

Results: Our 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.

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

Citing Articles

Srivastava V, Singh S Med J Armed Forces India. 2024; 80(1):4-9.

PMID: 38239603 PMC: 10793238. DOI: 10.1016/j.mjafi.2023.10.010.

Early goal-directed therapy vs usual care in the treatment of severe sepsis and septic shock: a systematic review and meta-analysis.

Rusconi A, Bossi I, Lampard J, Szava-Kovats M, Bellone A, Lang E Intern Emerg Med. 2015; 10(6):731-43.

PMID: 25982917 DOI: 10.1007/s11739-015-1248-y.

A systematic review and meta-analysis of early goal-directed therapy for septic shock: the ARISE, ProCESS and ProMISe Investigators.

Angus D, Barnato A, Bell D, Bellomo R, Chong C, Coats T Intensive Care Med. 2015; 41(9):1549-60.

PMID: 25952825 DOI: 10.1007/s00134-015-3822-1.

A randomized trial of protocol-based care for early septic shock.

Yealy D, Kellum J, Huang D, Barnato A, Weissfeld L, Pike F N Engl J Med. 2014; 370(18):1683-93.

PMID: 24635773 PMC: 4101700. DOI: 10.1056/NEJMoa1401602.

Integrating sepsis management recommendations into clinical care guidelines for district hospitals in resource-limited settings: the necessity to augment new guidelines with future research.

Jacob S, Lim M, Banura P, Bhagwanjee S, Bion J, Cheng A BMC Med. 2013; 11:107.

PMID: 23597160 PMC: 3635910. DOI: 10.1186/1741-7015-11-107.

References

Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B . Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2002; 345(19):1368-77. DOI: 10.1056/NEJMoa010307. View

Angus D, Linde-Zwirble W, Clermont G, Ball D, Basson B, Wesley Ely E . Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis. Crit Care Med. 2003; 31(1):1-11. DOI: 10.1097/00003246-200301000-00001. View

Lee M, Kong L, Weissfeld L . Multiple imputation for left-censored biomarker data based on Gibbs sampling method. Stat Med. 2012; 31(17):1838-48. DOI: 10.1002/sim.4503. View

Bang H, Davis C . On estimating treatment effects under non-compliance in randomized clinical trials: are intent-to-treat or instrumental variables analyses perfect solutions?. Stat Med. 2006; 26(5):954-64. DOI: 10.1002/sim.2663. View

Bonetti M, Gelber R . Patterns of treatment effects in subsets of patients in clinical trials. Biostatistics. 2004; 5(3):465-81. DOI: 10.1093/biostatistics/5.3.465. View

Shaw J, Johnson J, Coons S . US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005; 43(3):203-20. DOI: 10.1097/00005650-200503000-00003. View

Warren B, Eid A, Singer P, Pillay S, Carl P, Novak I . Caring for the critically ill patient. High-dose antithrombin III in severe sepsis: a randomized controlled trial. JAMA. 2001; 286(15):1869-78. DOI: 10.1001/jama.286.15.1869. View

Angus D, Clermont G, Watson R, Linde-Zwirble W, Clark R, Roberts M . Cost-effectiveness of inhaled nitric oxide in the treatment of neonatal respiratory failure in the United States. Pediatrics. 2003; 112(6 Pt 1):1351-60. DOI: 10.1542/peds.112.6.1351. View

Lui K . Comments on 'On estimating treatment effects under non-compliance in randomized clinical trials: are intent-to-treat or instrumental variables analyses perfect solutions?' by Heejung Bang and Clarence E. Davis, Statistics in Medicine 2007; 26:954-964. Stat Med. 2009; 28(3):531-4. DOI: 10.1002/sim.3479. View

10.

Vincent J, Moreno R, Takala J, Willatts S, de Mendonca A, Bruining H . The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996; 22(7):707-10. DOI: 10.1007/BF01709751. View

11.

McNamee R . Intention to treat, per protocol, as treated and instrumental variable estimators given non-compliance and effect heterogeneity. Stat Med. 2009; 28(21):2639-52. DOI: 10.1002/sim.3636. View

12.

Reade M, Huang D, Bell D, Coats T, Cross A, Moran J . Variability in management of early severe sepsis. Emerg Med J. 2010; 27(2):110-5. DOI: 10.1136/emj.2008.070912. View

13.

Jones A, Shapiro N, Trzeciak S, Arnold R, Claremont H, Kline J . Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010; 303(8):739-46. PMC: 2918907. DOI: 10.1001/jama.2010.158. View

14.

Hewitt C, Torgerson D, Miles J . Is there another way to take account of noncompliance in randomized controlled trials?. CMAJ. 2006; 175(4):347. PMC: 1534095. DOI: 10.1503/cmaj.051625. View

15.

. Understanding costs and cost-effectiveness in critical care: report from the second American Thoracic Society workshop on outcomes research. Am J Respir Crit Care Med. 2002; 165(4):540-50. DOI: 10.1164/ajrccm.165.4.16541. View

16.

Bernard G, Vincent J, Laterre P, LaRosa S, Dhainaut J, Lopez-Rodriguez A . Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001; 344(10):699-709. DOI: 10.1056/NEJM200103083441001. View

17.

Huang D, Angus D, Barnato A, Gunn S, Kellum J, Stapleton D . Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe. Intensive Care Med. 2013; 39(10):1760-75. PMC: 3864363. DOI: 10.1007/s00134-013-3024-7. View

18.

Shapiro N, Wolfe R, Moore R, Smith E, Burdick E, Bates D . Mortality in Emergency Department Sepsis (MEDS) score: a prospectively derived and validated clinical prediction rule. Crit Care Med. 2003; 31(3):670-5. DOI: 10.1097/01.CCM.0000054867.01688.D1. View

19.

Knaus W, Wagner D, Draper E, Zimmerman J, Bergner M, Bastos P . The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest. 1991; 100(6):1619-36. DOI: 10.1378/chest.100.6.1619. View

20.

Abraham E, Reinhart K, Opal S, Demeyer I, Doig C, Rodriguez A . Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA. 2003; 290(2):238-47. DOI: 10.1001/jama.290.2.238. View