Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial

doi:10.1186/s13063-016-1365-6

Randomized Controlled Trial

. 2016 May 6;17(1):238.

doi: 10.1186/s13063-016-1365-6.

Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial

Katharine O'Hearn¹, Dayre McNally^{2

3}, Karen Choong⁴, Anand Acharya⁵, Hector R Wong⁶, Margaret Lawson^{2

3}, Tim Ramsay^{7

8}, Lauralyn McIntyre⁹, Elaine Gilfoyle¹⁰, Marisa Tucci¹¹, David Wensley¹², Ronald Gottesman¹³, Gavin Morrison¹⁴, Kusum Menon^{2

3}; Canadian Critical Care Trials Group

Affiliations

¹ Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada. kohearn@cheo.on.ca.
² Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.
³ Department of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada.
⁴ McMaster Children's Hospital, McMaster University, Hamilton, Canada.
⁵ Department of Economics, Faculty of Public Affairs, Carleton University, Ottawa, Canada.
⁶ Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, USA.
⁷ Department of Epidemiology, University of Ottawa and Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
⁸ Clinical Epidemiology Program, The Ottawa Hospital Research Institute (OHRI), Ottawa, Canada.
⁹ Department of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
¹⁰ Section of Critical Care Medicine, Department of Pediatrics, Alberta Children's Hospital, Calgary, Canada.
¹¹ Department of Pediatrics, CHU Sainte-Justine Hospital, Montreal, Canada.
¹² Department of Pediatrics, Faculty of Medicine, The University of British Columbia, British Columbia Children's Hospital, Vancouver, Canada.
¹³ Department of Pediatrics, Faculty of Medicine, McGill University, Montreal Children's Hospital, Montreal, Canada.
¹⁴ Department of Critical Care Medicine, IWK Health Centre, Halifax, Canada.

PMID: 27153945
PMCID: PMC4859989
DOI: 10.1186/s13063-016-1365-6

Randomized Controlled Trial

Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial

Katharine O'Hearn et al. Trials. 2016.

. 2016 May 6;17(1):238.

doi: 10.1186/s13063-016-1365-6.

Authors

Affiliations

¹ Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada. kohearn@cheo.on.ca.
² Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.
³ Department of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada.
⁴ McMaster Children's Hospital, McMaster University, Hamilton, Canada.
⁵ Department of Economics, Faculty of Public Affairs, Carleton University, Ottawa, Canada.
⁶ Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, USA.
⁷ Department of Epidemiology, University of Ottawa and Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
⁸ Clinical Epidemiology Program, The Ottawa Hospital Research Institute (OHRI), Ottawa, Canada.
⁹ Department of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
¹⁰ Section of Critical Care Medicine, Department of Pediatrics, Alberta Children's Hospital, Calgary, Canada.
¹¹ Department of Pediatrics, CHU Sainte-Justine Hospital, Montreal, Canada.
¹² Department of Pediatrics, Faculty of Medicine, The University of British Columbia, British Columbia Children's Hospital, Vancouver, Canada.
¹³ Department of Pediatrics, Faculty of Medicine, McGill University, Montreal Children's Hospital, Montreal, Canada.
¹⁴ Department of Critical Care Medicine, IWK Health Centre, Halifax, Canada.

PMID: 27153945
PMCID: PMC4859989
DOI: 10.1186/s13063-016-1365-6

Abstract

Background: Physicians often administer corticosteroids for the treatment of fluid and vasoactive infusion dependent pediatric shock. This use of corticosteroids is controversial, however, and has never been studied in a pediatric randomized controlled trial (RCT). This pilot trial will determine the feasibility of a larger RCT on the role of corticosteroids in pediatric shock.

Methods/design: Steroids in Fluid and/or Vasoactive Infusion Dependent Pediatric Shock (STRIPES) is a pragmatic, seven-center, double-blind, pilot RCT. We aim to randomize 72 pediatric patients with fluid and vasoactive infusion dependent shock to receive either hydrocortisone or a saline placebo for 7 days or until clinical stability, whichever occurs first. The primary outcome of this pilot trial is the feasibility of recruitment, defined as the number of patients enrolled over a 1-year period. Secondary outcomes include the frequency of, and reasons for, open-label steroid use, protocol adherence, incidence of mortality and corticosteroid-associated adverse events, time to discontinuation of inotropes, and feasibility of blood sampling.

Discussion: Corticosteroids are used for the treatment of pediatric shock without sufficient evidence to support this practice. While there is a scientific rationale and limited data supporting their use in this setting, there is also evidence from other populations suggesting potential harm. The STRIPES pilot study will assess the feasibility of a larger, much needed trial powered for clinically important outcomes.

Trial registration: ClinicalTrials.gov: NCT02044159.

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Figures

**Fig. 1**
Protocol flow diagram for the STRIPES pilot study

See this image and copyright information in PMC

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Corticosteroids in Pediatric Septic Shock: A Narrative Review.
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References

1. Pollack MM, Patel KM, Ruttimann UE. PRISM III: an updated Pediatric Risk of Mortality score. Crit Care Med. 1996;24(5):743–52. doi: 10.1097/00003246-199605000-00004. - DOI - PubMed
1. Valoor HT, Singhi S, Jayashree M. Low-dose hydrocortisone in pediatric septic shock: an exploratory study in a third world setting. Pediatr Crit Care Med. 2009;10(1):121–5. doi: 10.1097/PCC.0b013e3181936ab3. - DOI - PubMed
1. Slusher T, Gbadero D, Howard C, Lewison L, Giroir B, Toro L, et al. Randomized, placebo-controlled, double blinded trial of dexamethasone in African children with sepsis. Pediatr Infect Dis J. 1996;15(7):579–83. doi: 10.1097/00006454-199607000-00004. - DOI - PubMed
1. Odetola FO, Gebremariam A, Freed GL. Patient and hospital correlates of clinical outcomes and resource utilization in severe pediatric sepsis. Pediatrics. 2007;119(3):487–94. doi: 10.1542/peds.2006-2353. - DOI - PubMed
1. Kissoon N, Carcillo JA, Espinosa V, Argent A, Devictor D, Madden M, et al. World Federation of Pediatric Intensive Care and Critical Care Societies: Global Sepsis Initiative. Pediatr Crit Care Med. 2011;12(5):494–503. doi: 10.1097/PCC.0b013e318207096c. - DOI - PubMed

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[1] Pollack MM, Patel KM, Ruttimann UE. PRISM III: an updated Pediatric Risk of Mortality score. Crit Care Med. 1996;24(5):743–52. doi: 10.1097/00003246-199605000-00004. - DOI - PubMed

[2] Pollack MM, Patel KM, Ruttimann UE. PRISM III: an updated Pediatric Risk of Mortality score. Crit Care Med. 1996;24(5):743–52. doi: 10.1097/00003246-199605000-00004. - DOI - PubMed

[3] Valoor HT, Singhi S, Jayashree M. Low-dose hydrocortisone in pediatric septic shock: an exploratory study in a third world setting. Pediatr Crit Care Med. 2009;10(1):121–5. doi: 10.1097/PCC.0b013e3181936ab3. - DOI - PubMed

[4] Valoor HT, Singhi S, Jayashree M. Low-dose hydrocortisone in pediatric septic shock: an exploratory study in a third world setting. Pediatr Crit Care Med. 2009;10(1):121–5. doi: 10.1097/PCC.0b013e3181936ab3. - DOI - PubMed

[5] Slusher T, Gbadero D, Howard C, Lewison L, Giroir B, Toro L, et al. Randomized, placebo-controlled, double blinded trial of dexamethasone in African children with sepsis. Pediatr Infect Dis J. 1996;15(7):579–83. doi: 10.1097/00006454-199607000-00004. - DOI - PubMed

[6] Slusher T, Gbadero D, Howard C, Lewison L, Giroir B, Toro L, et al. Randomized, placebo-controlled, double blinded trial of dexamethasone in African children with sepsis. Pediatr Infect Dis J. 1996;15(7):579–83. doi: 10.1097/00006454-199607000-00004. - DOI - PubMed

[7] Odetola FO, Gebremariam A, Freed GL. Patient and hospital correlates of clinical outcomes and resource utilization in severe pediatric sepsis. Pediatrics. 2007;119(3):487–94. doi: 10.1542/peds.2006-2353. - DOI - PubMed

[8] Odetola FO, Gebremariam A, Freed GL. Patient and hospital correlates of clinical outcomes and resource utilization in severe pediatric sepsis. Pediatrics. 2007;119(3):487–94. doi: 10.1542/peds.2006-2353. - DOI - PubMed

[9] Kissoon N, Carcillo JA, Espinosa V, Argent A, Devictor D, Madden M, et al. World Federation of Pediatric Intensive Care and Critical Care Societies: Global Sepsis Initiative. Pediatr Crit Care Med. 2011;12(5):494–503. doi: 10.1097/PCC.0b013e318207096c. - DOI - PubMed

[10] Kissoon N, Carcillo JA, Espinosa V, Argent A, Devictor D, Madden M, et al. World Federation of Pediatric Intensive Care and Critical Care Societies: Global Sepsis Initiative. Pediatr Crit Care Med. 2011;12(5):494–503. doi: 10.1097/PCC.0b013e318207096c. - DOI - PubMed

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Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial

Affiliations

Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial

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