Influence of in-line microfilters on systemic inflammation in adult critically ill patients: a prospective, randomized, controlled open-label trial

Ilse Gradwohl-Matis, Andreas Brunauer, Daniel Dankl, Elisabeth Wirthel, Ingeborg Meburger, Angela Bayer, Michaela Mandl, Martin W Dünser, Wilhelm Grander, Ilse Gradwohl-Matis, Andreas Brunauer, Daniel Dankl, Elisabeth Wirthel, Ingeborg Meburger, Angela Bayer, Michaela Mandl, Martin W Dünser, Wilhelm Grander

Abstract

Background: In critically ill children, in-line microfilters may reduce the incidence of the systemic inflammatory response syndrome (SIRS), the overall complication and organ dysfunction rate. No data on the use of in-line microfilters exist in critically ill adults.

Methods: In this prospective, randomized, controlled open-label study, we evaluated the influence of in-line microfilters on systemic immune activation in 504 critically ill adults with a central venous catheter in place and an expected length of stay in the intensive care unit >24 h. Patients were randomized to have in-line microfilters placed into all intravenous lines (intervention group) or usual care (control group). The primary endpoint was the number of intensive care unit days with SIRS. Secondary endpoints were the incidence of SIRS, SIRS criteria per day, duration of invasive mechanical ventilation, intensive care unit length of stay, the incidence of acute lung injury, maximum C-reactive protein, maximum white blood cell count, incidence of new candida and/or central-line-associated bloodstream infections, incidence of new thromboembolic complications, cumulative insulin requirements and presence of hyper- or hypoglycemia.

Results: The study groups did not differ in any baseline variable. There was no difference in the number of days in the intensive care unit with SIRS between microfilter and control patients [2 (0.8-4.7) vs. 1.8 (0.7-4.4), p = 0.62]. Except for a higher incidence of SIRS in microfilter patients (99.6 vs. 96.8 %, p = 0.04), no difference between the groups was observed in any secondary outcome parameter. Results did not change when only patients with an intensive care unit length of stay of greater than 7 days were included in the analysis. The rate of adverse events was comparable between microfilter and control patients. In two patients allocated to the microfilter group, the study intervention was discontinued for technical reasons. Use of in-line microfilters was associated with additional costs.

Conclusions: The use of in-line microfilters failed to modulate systemic inflammation and clinical outcome parameters in critically ill adults.

Trial registration: Clinical Trials NCT01534390.

Keywords: Adults; C-Reactive protein; Critically ill; In-line microfilter; Systemic inflammation.

Figures

Fig. 1
Fig. 1
Schematic overview of different sized and colored in-line filters on a central venous catheter
Fig. 2
Fig. 2
Overview of patient enrollment. ICU intensive care unit, LOS length of stay
Fig. 3
Fig. 3
Differences in the maximum white blood cell count and C-reactive protein levels between study groups

References

    1. Oie S, Kamiya A. Particulate and microbial contamination in in-use admixed parenteral nutrition solutions. Biol Pharm Bull. 2005;28:2268–2270. doi: 10.1248/bpb.28.2268.
    1. Yorioka K, Oie S, Oomaki M, Imamura A, Kamiya A. Particulate and microbial contamination in in-use admixed intravenous infusions. Biol Pharm Bull. 2006;29:2321–2323. doi: 10.1248/bpb.29.2321.
    1. Lehr HA, Brunner J, Rangoonwala R, Kirkpatrick CJ. Particulate matter contamination of intravenous antibiotics aggravates loss of functional capillary density in postischemic striated muscle. Am J Respir Crit Care Med. 2002;165:514–520. doi: 10.1164/ajrccm.165.4.2108033.
    1. Nemec K, kopelent-Frank H, Greif R. Standardization of infusion solutions to reduce the risk of incompatibility. Am J Health Syst Pharm. 2008;65:1648-54.
    1. Jack T, Brent BE, Boehne M, Müller M, Sewald K, Braun A, et al. Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med. 2009;36:707–711. doi: 10.1007/s00134-010-1775-y.
    1. Burdon D, Zabel P. Acute phase reaction and immunocompetence in sepsis and SIRS. Wien Klin Wochenschr. 2002;114(Suppl 1):1–8.
    1. Garvan JM, Gunner BW. The harmful effects of particles in intravenous fluids. Med J Aust. 1983;2:1–6.
    1. Walpot H, Franke RP, Burchard WG, Agternkamp C, Mueller FG, Mittermayer C, et al. Particulate contamination of infusion solutions and drug additives within the scope of long-term intensive therapy. Anaesthesist. 1989;38:544–548.
    1. Puntis JW, Wilkins KM, Ball PA, Rushton DI, Booth IW. Hazards of parenteral treatment: do particles count? Arch Dis Child. 1992;67:1475–1477. doi: 10.1136/adc.67.12.1475.
    1. Bruning EJ. Pathogenesis and significance of intra-arterial foreign body embolisms of the lung in children. Virchows Arch. 1955;327:460–479. doi: 10.1007/BF00955940.
    1. Ball PA. Intravenous in-line filters: filtering the evidence. Curr Opin Clin Nutr Metab Care. 2003;6:319–325.
    1. Bethune K, Allwood M, Grainger C, Wormleighton C. Use of filters during the preparation and administration of parenteral nutrition: position paper and guidelines prepared by a british pharmaceutical nutrition group working party. Nutrition. 2001;17:403–408. doi: 10.1016/S0899-9007(01)00536-6.
    1. Jack T, Boehne M, Brent BE, Hoy L, Köditz H, Wessel A, et al. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med. 2012;38:1008–1016. doi: 10.1007/s00134-012-2539-7.
    1. Boehne M, Jack T, Köditz H, Seidemann K, Schmidt F, Abura M, et al. In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial. BMC Pediatrics. 2013;13:21.
    1. Van Lingen RA, Baerts W, Marquering ACM, Ruijs GJHM. The use of in-line intravenous filters in sick newborn infants. Acta Paediatr. 2004;93:658–662. doi: 10.1111/j.1651-2227.2004.tb02993.x.
    1. Sasse M, Dziuba F, Jack T, Köditz H, Kaussen T, Bertram H, et al. In-line filtration decreases systemic inflammatory response syndrome, renal and hematologic dysfunction in pediatric cardiac intensive care patients. Pediatr Cardiol. 2015;36:1270–1278. doi: 10.1007/s00246-015-1157-x.
    1. No authors listed American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992;20:864–874. doi: 10.1097/00003246-199206000-00025.
    1. Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, et al. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med. 1994;149:818-24.
    1. Povoa P. C-reactive protein: a valuable marker of sepsis. Intensive Care Med. 2002;28:235–243. doi: 10.1007/s00134-002-1209-6.
    1. Pfaffin A, Schleicher E. Inflammation markers in point-of-care testing (POCT) Anal Bioanal Chem. 2009;393:1473–1480. doi: 10.1007/s00216-008-2561-3.
    1. Crimi E, Slutsky AS. Inflammation and the acute respiratory distress syndrome. Best Pract Res Clin Anaesthesiol. 2004;18:477–492. doi: 10.1016/j.bpa.2003.12.007.
    1. Foster JP, Richards R, Showell MG, Jones LJ. Intravenous in-line filters for preventing morbidity and mortality in neonates. Cochrane Database Syst Rev 2015;8:CD005248.
    1. Brivet FG, Kleinknecht DJ, Loirat P, Landais PJ. Acute renal failure in intensive care units - causes, outcome, and prognostic factors of hospital mortality. Crit Care Med. 1996;24:192–198. doi: 10.1097/00003246-199602000-00003.
    1. Savovic J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized controlled trials. Ann Intern Med. 2012;157:429–438. doi: 10.7326/0003-4819-157-6-201209180-00537.
    1. Bafeta A, Dechartres A, Trinquart L, Yavchitz A, Boutron I, Ravaud P. Impact of single centre status on estimates of intervention effects in trials with continuous outcomes: meta-epidemiological study. BMJ. 2012;344:e813. doi: 10.1136/bmj.e813.

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