A prospective randomized controlled study of two fluid regimens in the initial management of septic shock in the emergency department.
OBJECTIVE
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.


METHODS
Prospective randomized controlled study in the emergency department of a public hospital in India.


METHODS
One hundred forty-seven children older than 1 month presenting with septic shock were enrolled into the study.


METHODS
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).


CONCLUSIONS
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.
Santhanam
Indumathy
I
Pediatric Emergency Medicine, Institute of Child Health and Hospital for Children, Madras Medical College, Chennai, India.
Sangareddi
Shanthi
S
Venkataraman
Shekhar
S
Kissoon
Niranjan
N
Thiruvengadamudayan
Vaidehi
V
Kasthuri
R Kulandhai
RK
D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004231:Diuresis; D004298:Dopamine / Q000008:administration & dosage / Q000627:therapeutic use*; D004632:Emergency Medical Services / Q000379:methods*; D004636:Emergency Service, Hospital; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006529:Hepatomegaly / Q000453:epidemiology / Q000209:etiology; D017052:Hospital Mortality; D006801:Humans; D000860:Hypoxia / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D007223:Infant; D007442:Intubation, Intratracheal / Q000706:statistics & numerical data; D007552:Isotonic Solutions / Q000008:administration & dosage / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D011446:Prospective Studies; D011654:Pulmonary Edema / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D012121:Respiration, Artificial / Q000706:statistics & numerical data; D000077325:Ringer's Lactate; D012772:Shock, Septic / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*
D007552:Isotonic Solutions; D000077325:Ringer's Lactate; D004298:Dopamine