Comparative study on the outcome of Early Goal Directed Therapy (EGDT) versus standard care in pediatric septic shock patients: A prospective open labeled randomized controlled trial

Abstract

Background : Sepsis in children is a noteworthy cause of morbidity and mortality all over the world. Given the crucial need to reduce the mortality from sepsis, conflicting results from adult studies and lack of high quality pediatric controlled study warrant a trial to examine the effectiveness of early goal directed therapy (EGDT) versus standard care in Indian patients. Methods : The trial was a prospective open labeled randomized controlled trial conducted from 1st July 2015 to 30th June 2017. All children from one month of age to 12 years with septic shock fulfilling the inclusion criteria were enrolled in the study. Eligible patients were randomized and allocated one of the two study groups (EGDT Group and standard care group). If the patient was assigned to EGDT, the EGDT protocol adapted from Rivers et al. was commenced by the treating team within one hour of enrollment. If the patient was assigned to standard care, no changes were made to the plan of the treating team. Results : The 110 patients were recruited from July 2015 to June 2017. Out of 110 patients, 54 patients were randomized to the EGDT group and 56 randomized to the standard care group. The trial had to be stopped after an interim analysis by the independent data monitoring committee indicated the futility of the study. The overall all-cause mortality at 28 days of the study population was 53.6%. Children in the EGDT group had 46.3% mortality while children in the standard care group had 60.7% mortality (p=0.13). There was 14.4% absolute risk reduction of mortality in the EGDT group. There was no difference in any secondary outcome regarding the proportion of patients achieving therapeutic end points at 6 hours, use and duration of organ support, SOFA and PeLOD score and length of PICU and hospital stay. Conclusion : Our study suggests that the implementation of the early goal directed therapy (EGDT) by the addition of intermittent ScvO2 monitoring and protocolized management did not improve mortality in the EGDT group compared to standard care group. The implementation of EGDT needed the greater intensity of treatment in the form of inotrope and packed RBCs transfusion requirement.