Health Condition 1: null- Septic shock
Conditions
Interventions
Intervention1: Normal Saline: 20 mL/Kg intravenous, frequency is decided by the clinical response.
Control Intervention1: Plasmalyte: 20 mL/Kg, intrvenous
Frequency is decided by the clinical response
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: All children presenting to pediatric emergency with septic shock requiring fluid boluses will be enrolled into the study. Septic shock will be defined as sepsis and hypotension as systolic blood pressure less than 70 mm Hg in infant and less than 70 plus age times two after 1 year of age or three of the following four clinical signs: viz o decreased pulse volume o capillary filling time more than or equal to 3 sec o tachycardia as per age appropriate norms and o urine output less than 1 mL/kg/hr or less than 20 mL/hr in 20 kg or above child
Exclusion criteria
Exclusion criteria: Children with preexisting/ established renal disease, Children with underlying liver disorders, Children with preexisting cardiac diseases, Children with raised ICP,Children with hyperkalemia, Children who had received fluid boluses outside
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in serum creatinine levels from baseline to peakTimepoint: At 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of children requiring RRTTimepoint: during hospital stay;Proportion of in hospital mortalityTimepoint: during hospital stay;Proportion of patients developing new/progressive AKI (defined by change in creatinine as per KDIGO)Timepoint: during hospital stay;Time to different events (e.g. AKI, Metabolic acidosis, death etc.)Timepoint: during hospital stay;Change in chloride levels, pH and bicarbonate levels (baseline to 24 hrs.)Timepoint: 24 hours;Changes in the base excessTimepoint: 24 hours;Length of ICU / hospital stayTimepoint: during hospital stay;Length of MVTimepoint: during hospital stay;Proportion of children requiring mechanical ventilationTimepoint: during hospital stay | — |
Countries
India
Contacts
Public ContactM Jayashree
PGIMER
Outcome results
None listed