In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial

Abstract

Purpose: Particulate contamination due to infusion therapy carries a potential health risk for intensive care patients.

Methods: This single-centre, prospective, randomized controlled trial assessed the effects of filtration of intravenous fluids on the reduction of complications in critically ill children admitted to a pediatric intensive care unit (PICU). A total of 807 subjects were randomly assigned to either a control (n = 406) or filter group (n = 401), with the latter receiving in-line filtration. The primary endpoint was reduction in the rate of overall complications, which included the occurrence of systemic inflammatory response syndrome (SIRS), sepsis, organ failure (circulation, lung, liver, kidney) and thrombosis. Secondary objectives were a reduction in the length of stay on the PICU and overall hospital stay. Duration of mechanical ventilation and mortality were also analyzed.

Findings: Analysis demonstrated a significant reduction in the overall complication rate (n = 166 [40.9 %] vs. n = 124 [30.9 %]; P = 0.003) for the filter group. In particular, the incidence of SIRS was significantly lower (n = 123 [30.3 %] vs. n = 90 [22.4 %]; P = 0.01). Moreover the length of stay on PICU (3.89 [95 % confidence interval 2.97-4.82] vs. 2.98 [2.33-3.64]; P = 0.025) and duration of mechanical ventilation (14.0 [5.6-22.4] vs. 11.0 [7.1-14.9] h; P = 0.028) were significantly reduced.

Conclusion: In-line filtration is able to avert severe complications in critically ill patients. The overall complication rate during the PICU stay among the filter group was significantly reduced. In-line filtration was effective in reducing the occurrence of SIRS. We therefore conclude that in-line filtration improves the safety of intensive care therapy and represents a preventive strategy that results in a significant reduction of the length of stay in the PICU and duration of mechanical ventilation (ClinicalTrials.gov number: NCT00209768).

Fig. 1

Enrolment of study subjects. Single asterisk denotes exclusion criteria: recruitment for other studies, 18 years of age or older, no infusion therapy during the stay in the pediatric intensive care unit (PICU). Double asterisk denotes other reasons for exclusion: no informed consent due to foreign language and ethical reasons. In four patients allocated to the filter group the intervention was discontinued. One patient in the control group and 8 patients in the filter group were excluded due to incorrect allocation. Fourteen patients (8 control, 6 filter group) were excluded during the final validation because of incomplete data in the medical charts

Fig. 2

Hazard ratios of primary objectives for the treatment effect of in-line filtration. The incidence of overall complications and systemic inflammatory response syndrome (SIRS) were significantly reduced in the filter group. A trend towards a reduction in acute respiratory distress syndrome (ARDS) was evident for the filter group (P = 0.08). No significant differences were found for the incidence of sepsis, circulatory failure, acute renal failure, acute liver failure and thrombosis. Filled rhombi Hazard ratios, horizontal lines 95 % confidence intervals

Fig. 3

Kaplan–Meier analysis for complication-free interval (a) or SIRS-free interval (b). Control (blue filled circle) and filter (red open rhombus) group (maximum PICU stay 28 days). Circles and rhombi indicate censored patients