OBJECTIVES: To compare the impact of 40 mL/kg of fluid over 15 minutes followed by dopamine and further titration of therapy to achieve therapeutic goals (study protocol) versus 20 mL/kg over 20 minutes up to a maximum of 60 mL/kg over 1 hour followed by dopamine (control protocol) in septic shock. DESIGN AND SETTING: Prospective randomized controlled study in the emergency department of a public hospital in India. PATIENTS: One hundred forty-seven children older than 1 month presenting with septic shock were enrolled into the study. OUTCOME MEASURES: Hospital mortality (primary outcome), 72-hour survival, achievement of therapeutic goals of shock resolution, incidence of hypoxia, hepatomegaly, intubation at 20, 40, and 60 minutes (secondary outcomes) were compared between the arms. RESULTS:Seventy-four and 73 children were assigned to the study and control group, respectively. Overall mortality was 17.6%, 26 deaths with 13 in each arm. Mortality in the study cohort was lower than our historical mortality of 50% (P<0.0001), 95% confidence interval (CI), 11.9-24.8. Cumulative survival at 72 hours was 72.5% (95% CI, 58.9-86.1) and 77.6% (95% CI, 66.0%-89.2%) in the control and study groups, respectively. Resolution of shock in the emergency department was associated with survival odds ratio (OR) 9.2 (95% CI, 2.1-40.8). Rapidity of achieving therapeutic goals was not significantly different between groups. Intubation rates were also the same (46.5% in the control group versus 55% in the study group; P=0.28). At 20 minutes, 35.6% of the control group and 70% of the study group had hepatomegaly (P<0.01). CONCLUSION: There was no difference in the overall mortality, rapidity of shock resolution, or incidence of complications between the groups. The occurrence of hepatomegaly at 20 minutes following 40 mL/kg is of concern in settings with limited access to post-resuscitation ventilator care.
RCT Entities:
OBJECTIVES: To compare the impact of 40 mL/kg of fluid over 15 minutes followed by dopamine and further titration of therapy to achieve therapeutic goals (study protocol) versus 20 mL/kg over 20 minutes up to a maximum of 60 mL/kg over 1 hour followed by dopamine (control protocol) in septic shock. DESIGN AND SETTING: Prospective randomized controlled study in the emergency department of a public hospital in India. PATIENTS: One hundred forty-seven children older than 1 month presenting with septic shock were enrolled into the study. OUTCOME MEASURES: Hospital mortality (primary outcome), 72-hour survival, achievement of therapeutic goals of shock resolution, incidence of hypoxia, hepatomegaly, intubation at 20, 40, and 60 minutes (secondary outcomes) were compared between the arms. RESULTS: Seventy-four and 73 children were assigned to the study and control group, respectively. Overall mortality was 17.6%, 26 deaths with 13 in each arm. Mortality in the study cohort was lower than our historical mortality of 50% (P<0.0001), 95% confidence interval (CI), 11.9-24.8. Cumulative survival at 72 hours was 72.5% (95% CI, 58.9-86.1) and 77.6% (95% CI, 66.0%-89.2%) in the control and study groups, respectively. Resolution of shock in the emergency department was associated with survival odds ratio (OR) 9.2 (95% CI, 2.1-40.8). Rapidity of achieving therapeutic goals was not significantly different between groups. Intubation rates were also the same (46.5% in the control group versus 55% in the study group; P=0.28). At 20 minutes, 35.6% of the control group and 70% of the study group had hepatomegaly (P<0.01). CONCLUSION: There was no difference in the overall mortality, rapidity of shock resolution, or incidence of complications between the groups. The occurrence of hepatomegaly at 20 minutes following 40 mL/kg is of concern in settings with limited access to post-resuscitation ventilator care.
Authors: Kusum Menon; James Dayre McNally; Jerry J Zimmerman; Michael S D Agus; Katie O'Hearn; R Scott Watson; Hector R Wong; Mark Duffett; David Wypij; Karen Choong Journal: Pediatr Crit Care Med Date: 2017-03 Impact factor: 3.624
Authors: Scott L Weiss; Mark J Peters; Waleed Alhazzani; Michael S D Agus; Heidi R Flori; David P Inwald; Simon Nadel; Luregn J Schlapbach; Robert C Tasker; Andrew C Argent; Joe Brierley; Joseph Carcillo; Enitan D Carrol; Christopher L Carroll; Ira M Cheifetz; Karen Choong; Jeffry J Cies; Andrea T Cruz; Daniele De Luca; Akash Deep; Saul N Faust; Claudio Flauzino De Oliveira; Mark W Hall; Paul Ishimine; Etienne Javouhey; Koen F M Joosten; Poonam Joshi; Oliver Karam; Martin C J Kneyber; Joris Lemson; Graeme MacLaren; Nilesh M Mehta; Morten Hylander Møller; Christopher J L Newth; Trung C Nguyen; Akira Nishisaki; Mark E Nunnally; Margaret M Parker; Raina M Paul; Adrienne G Randolph; Suchitra Ranjit; Lewis H Romer; Halden F Scott; Lyvonne N Tume; Judy T Verger; Eric A Williams; Joshua Wolf; Hector R Wong; Jerry J Zimmerman; Niranjan Kissoon; Pierre Tissieres Journal: Intensive Care Med Date: 2020-02 Impact factor: 17.440
Authors: R P Dellinger; Mitchell M Levy; Andrew Rhodes; Djillali Annane; Herwig Gerlach; Steven M Opal; Jonathan E Sevransky; Charles L Sprung; Ivor S Douglas; Roman Jaeschke; Tiffany M Osborn; Mark E Nunnally; Sean R Townsend; Konrad Reinhart; Ruth M Kleinpell; Derek C Angus; Clifford S Deutschman; Flavia R Machado; Gordon D Rubenfeld; Steven Webb; Richard J Beale; Jean-Louis Vincent; Rui Moreno Journal: Intensive Care Med Date: 2013-01-30 Impact factor: 17.440
Authors: Indumathy Santhanam; Niranjan Kissoon; S R Kamath; Suchitra Ranjit; Jayanthi Ramesh; Janani Shankar Journal: Indian J Crit Care Med Date: 2009 Apr-Jun