Daijiworld Media Network - New Delhi
New Delhi, Jul 18: Balanced crystalloid fluids do not reduce the risk of major adverse kidney events compared with normal saline in children treated for septic shock, according to a large international clinical trial that helps address the long-standing debate over the preferred fluid for paediatric resuscitation.
The pragmatic trial enrolled 9,041 children aged between two months and under 18 years who presented with suspected septic shock and abnormal perfusion at 47 emergency departments across five countries.
Participants were randomly assigned to receive either balanced crystalloid fluids or 0.9 per cent saline for up to 48 hours. After accounting for withdrawals, the final analysis included 4,235 children in the balanced fluid group and 4,247 in the saline group.
Researchers assessed the incidence of major adverse kidney events within 30 days of enrolment or by hospital discharge. The composite primary outcome included death, the need for newly initiated renal replacement therapy or persistent kidney dysfunction.
The primary outcome occurred in 137 children (3.4 per cent) who received balanced fluids compared with 124 children (3.0 per cent) treated with saline.
The difference of 0.4 percentage points was not statistically significant. The study reported a risk ratio of 1.10 with a 95 per cent confidence interval of 0.88 to 1.40, indicating no meaningful advantage of balanced fluids over saline in preventing kidney complications or death.
Median hospital-free days over the 28-day follow-up period were identical in both groups at 23 days.
Although the overall clinical outcomes were similar, researchers observed differences in certain laboratory parameters.
Hyperchloremia developed in 31.4 per cent of children receiving balanced fluids compared with 49 per cent of those given saline. Hypernatremia was also less common in the balanced fluid group, occurring in 1.8 per cent of patients compared with 3.1 per cent in the saline group.
However, hyperlactatemia was reported more frequently among children receiving balanced fluids, affecting 19.8 per cent of participants compared with 16.7 per cent in the saline group.
The study found no significant differences in other safety outcomes or adverse events between the two treatment groups.
The findings suggest that both balanced crystalloid fluids and normal saline provide comparable outcomes for survival and kidney health in children undergoing fluid resuscitation for septic shock, despite differences in electrolyte abnormalities.