Screening and study enrolment in the randomized evaluation of normal vs. augmented level (RENAL) replacement therapy trial

Rinaldo Bellomo, Alan Cass, Louise Cole, Simon Finfer, Martin Gallagher, Donna Goldsmith, John Myburgh, Robyn Norton, Carlos Scheinkestel, Ashoke Banarjee Deepak Bhonagiri, David Blythe, John Botha, John Cade, Geoff Dobb, John Eddington, Arthas Flabouris, Craig French, Peter Garrett, Seton J Henderson, Benno Ihle & 16 others Chris Joyce, Michael Kalkoff, Jeff Lipman, Colin McArthur, Shay McGinness, David Milliss, Imogen Mitchell, John Morgan, Priya V Nair, Neil Orford, Asif Raza, Yahya Shehabi, Antony Tobin, Richard Totaro, Andrew J Turner, Christopher Wright

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background and Objectives: Aspects of trial design, screening and study efficiency can affect recruitment and the findings of the trial itself. A clear understanding of the screening and study inclusion process will assist clinicians in interpreting trial results. Design: Prospective observational data collection on all patients screened for possible inclusion in a randomized controlled trial of normal vs. augmented renal replacement therapy in critically ill patients (the RENAL Trial). Setting: 35 hospitals in Australia and New Zealand. Participants: All patients screened for the RENAL Trial. Results: We screened 4,551 patients. Of these patients, 767 were ineligible because of lack of inclusion criteria and 2,085 because of exclusion criteria. Of the remaining 1,699, 1,508 (88.7%) were enrolled. The three most common exclusion criteria which prevented recruitment of potentially eligible patients were that the patient had end-stage kidney failure and was already on chronic dialysis (484; 23.2%), the patient's body weight was either <60 or >120 kg (456; 21.8%), and the fact that the patient had already received renal replacement therapy during the index admission. Important modifiable impediments to recruitment were inability to obtain consent in 191 cases, unavailability of research staff in 124 cases, physician objection in 89 cases, and inability to deliver the trial protocol in 78 cases. Conclusion: The RENAL Trial's enrolment efficiency was high and compared favourably with previous large intensive care units trials and with that of trials in patients with acute renal failure. The high rate of enrolment suggests that the results can be applied with confidence to most patients with de novo acute renal failure. The loss of close to 1.5% of patients due to consent issues highlights a common problem in critical care trials. The low rate of physician objection suggests clinical equipoise.

Original languageEnglish
Pages (from-to)199-205
Number of pages7
JournalBlood Purification
Volume27
Issue number2
DOIs
Publication statusPublished - Feb 2009

Keywords

  • CONSORT statement
  • Continuous renal replacement therapy
  • Renal replacement therapy
  • RENAL Trial
  • VA/NIH ATN study

Cite this

Bellomo, Rinaldo ; Cass, Alan ; Cole, Louise ; Finfer, Simon ; Gallagher, Martin ; Goldsmith, Donna ; Myburgh, John ; Norton, Robyn ; Scheinkestel, Carlos ; Bhonagiri, Ashoke Banarjee Deepak ; Blythe, David ; Botha, John ; Cade, John ; Dobb, Geoff ; Eddington, John ; Flabouris, Arthas ; French, Craig ; Garrett, Peter ; Henderson, Seton J ; Ihle, Benno ; Joyce, Chris ; Kalkoff, Michael ; Lipman, Jeff ; McArthur, Colin ; McGinness, Shay ; Milliss, David ; Mitchell, Imogen ; Morgan, John ; Nair, Priya V ; Orford, Neil ; Raza, Asif ; Shehabi, Yahya ; Tobin, Antony ; Totaro, Richard ; Turner, Andrew J ; Wright, Christopher. / Screening and study enrolment in the randomized evaluation of normal vs. augmented level (RENAL) replacement therapy trial. In: Blood Purification. 2009 ; Vol. 27, No. 2. pp. 199-205.
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abstract = "Background and Objectives: Aspects of trial design, screening and study efficiency can affect recruitment and the findings of the trial itself. A clear understanding of the screening and study inclusion process will assist clinicians in interpreting trial results. Design: Prospective observational data collection on all patients screened for possible inclusion in a randomized controlled trial of normal vs. augmented renal replacement therapy in critically ill patients (the RENAL Trial). Setting: 35 hospitals in Australia and New Zealand. Participants: All patients screened for the RENAL Trial. Results: We screened 4,551 patients. Of these patients, 767 were ineligible because of lack of inclusion criteria and 2,085 because of exclusion criteria. Of the remaining 1,699, 1,508 (88.7{\%}) were enrolled. The three most common exclusion criteria which prevented recruitment of potentially eligible patients were that the patient had end-stage kidney failure and was already on chronic dialysis (484; 23.2{\%}), the patient's body weight was either <60 or >120 kg (456; 21.8{\%}), and the fact that the patient had already received renal replacement therapy during the index admission. Important modifiable impediments to recruitment were inability to obtain consent in 191 cases, unavailability of research staff in 124 cases, physician objection in 89 cases, and inability to deliver the trial protocol in 78 cases. Conclusion: The RENAL Trial's enrolment efficiency was high and compared favourably with previous large intensive care units trials and with that of trials in patients with acute renal failure. The high rate of enrolment suggests that the results can be applied with confidence to most patients with de novo acute renal failure. The loss of close to 1.5{\%} of patients due to consent issues highlights a common problem in critical care trials. The low rate of physician objection suggests clinical equipoise.",
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author = "Rinaldo Bellomo and Alan Cass and Louise Cole and Simon Finfer and Martin Gallagher and Donna Goldsmith and John Myburgh and Robyn Norton and Carlos Scheinkestel and Bhonagiri, {Ashoke Banarjee Deepak} and David Blythe and John Botha and John Cade and Geoff Dobb and John Eddington and Arthas Flabouris and Craig French and Peter Garrett and Henderson, {Seton J} and Benno Ihle and Chris Joyce and Michael Kalkoff and Jeff Lipman and Colin McArthur and Shay McGinness and David Milliss and Imogen Mitchell and John Morgan and Nair, {Priya V} and Neil Orford and Asif Raza and Yahya Shehabi and Antony Tobin and Richard Totaro and Turner, {Andrew J} and Christopher Wright",
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Bellomo, R, Cass, A, Cole, L, Finfer, S, Gallagher, M, Goldsmith, D, Myburgh, J, Norton, R, Scheinkestel, C, Bhonagiri, ABD, Blythe, D, Botha, J, Cade, J, Dobb, G, Eddington, J, Flabouris, A, French, C, Garrett, P, Henderson, SJ, Ihle, B, Joyce, C, Kalkoff, M, Lipman, J, McArthur, C, McGinness, S, Milliss, D, Mitchell, I, Morgan, J, Nair, PV, Orford, N, Raza, A, Shehabi, Y, Tobin, A, Totaro, R, Turner, AJ & Wright, C 2009, 'Screening and study enrolment in the randomized evaluation of normal vs. augmented level (RENAL) replacement therapy trial' Blood Purification, vol. 27, no. 2, pp. 199-205. https://doi.org/10.1159/000195091

Screening and study enrolment in the randomized evaluation of normal vs. augmented level (RENAL) replacement therapy trial. / Bellomo, Rinaldo; Cass, Alan; Cole, Louise; Finfer, Simon; Gallagher, Martin; Goldsmith, Donna; Myburgh, John; Norton, Robyn; Scheinkestel, Carlos; Bhonagiri, Ashoke Banarjee Deepak; Blythe, David; Botha, John; Cade, John; Dobb, Geoff; Eddington, John; Flabouris, Arthas; French, Craig; Garrett, Peter; Henderson, Seton J; Ihle, Benno; Joyce, Chris; Kalkoff, Michael; Lipman, Jeff; McArthur, Colin; McGinness, Shay; Milliss, David; Mitchell, Imogen; Morgan, John; Nair, Priya V; Orford, Neil; Raza, Asif; Shehabi, Yahya; Tobin, Antony; Totaro, Richard; Turner, Andrew J; Wright, Christopher.

In: Blood Purification, Vol. 27, No. 2, 02.2009, p. 199-205.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - Screening and study enrolment in the randomized evaluation of normal vs. augmented level (RENAL) replacement therapy trial

AU - Bellomo, Rinaldo

AU - Cass, Alan

AU - Cole, Louise

AU - Finfer, Simon

AU - Gallagher, Martin

AU - Goldsmith, Donna

AU - Myburgh, John

AU - Norton, Robyn

AU - Scheinkestel, Carlos

AU - Bhonagiri, Ashoke Banarjee Deepak

AU - Blythe, David

AU - Botha, John

AU - Cade, John

AU - Dobb, Geoff

AU - Eddington, John

AU - Flabouris, Arthas

AU - French, Craig

AU - Garrett, Peter

AU - Henderson, Seton J

AU - Ihle, Benno

AU - Joyce, Chris

AU - Kalkoff, Michael

AU - Lipman, Jeff

AU - McArthur, Colin

AU - McGinness, Shay

AU - Milliss, David

AU - Mitchell, Imogen

AU - Morgan, John

AU - Nair, Priya V

AU - Orford, Neil

AU - Raza, Asif

AU - Shehabi, Yahya

AU - Tobin, Antony

AU - Totaro, Richard

AU - Turner, Andrew J

AU - Wright, Christopher

PY - 2009/2

Y1 - 2009/2

N2 - Background and Objectives: Aspects of trial design, screening and study efficiency can affect recruitment and the findings of the trial itself. A clear understanding of the screening and study inclusion process will assist clinicians in interpreting trial results. Design: Prospective observational data collection on all patients screened for possible inclusion in a randomized controlled trial of normal vs. augmented renal replacement therapy in critically ill patients (the RENAL Trial). Setting: 35 hospitals in Australia and New Zealand. Participants: All patients screened for the RENAL Trial. Results: We screened 4,551 patients. Of these patients, 767 were ineligible because of lack of inclusion criteria and 2,085 because of exclusion criteria. Of the remaining 1,699, 1,508 (88.7%) were enrolled. The three most common exclusion criteria which prevented recruitment of potentially eligible patients were that the patient had end-stage kidney failure and was already on chronic dialysis (484; 23.2%), the patient's body weight was either <60 or >120 kg (456; 21.8%), and the fact that the patient had already received renal replacement therapy during the index admission. Important modifiable impediments to recruitment were inability to obtain consent in 191 cases, unavailability of research staff in 124 cases, physician objection in 89 cases, and inability to deliver the trial protocol in 78 cases. Conclusion: The RENAL Trial's enrolment efficiency was high and compared favourably with previous large intensive care units trials and with that of trials in patients with acute renal failure. The high rate of enrolment suggests that the results can be applied with confidence to most patients with de novo acute renal failure. The loss of close to 1.5% of patients due to consent issues highlights a common problem in critical care trials. The low rate of physician objection suggests clinical equipoise.

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KW - CONSORT statement

KW - Continuous renal replacement therapy

KW - Renal replacement therapy

KW - RENAL Trial

KW - VA/NIH ATN study

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