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Micro Particles Contamination: Innocent Bystander or Real Threat ?

IFAD Antwerpen 2012. Micro Particles Contamination: Innocent Bystander or Real Threat ?. Thomas Jack; MD Dept. of Pediatric Cardiology and Intensive Care Medicine. Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel.

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Micro Particles Contamination: Innocent Bystander or Real Threat ?

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  1. IFAD Antwerpen 2012 Micro Particles Contamination: Innocent Bystander or Real Threat ? Thomas Jack; MD Dept. of Pediatric Cardiology and Intensive Care Medicine Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  2. Disclosure Pall Corporation B. Braun Melsungen AG Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  3. Background: Particles and intravenous therapy • Particulate contamination during intravenous therapy has been described for many years [1]. • In an intensive care setting it has been estimated that up to one million particles per patient per day may be infused [2] Different effects are proven [3,4,5]: • Embolisation • Thrombogenic effects • Immunomodulation • Impairment of microcirculation [1] Garvan JM & Gunner BW. The harmful effects of particles in intravenous fluids. Med. J. Austr. 1964. 41 (2):1-6. [2] Mehrkens HH. Klin Anasthesiol Intensivther. 1977 (14):106-13. [3] Walpot H. Anaesthesist.1989 Nov;38(11):617-21. [4] Puntis JW. Arch Dis Child. 1992 Dec;67(12):1475-7. [5] Lehr HA. Am J Respir Crit Care Med. 2002 Feb 15;165(4):514-20. Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  4. Origin of particles 1. Drug incompatibility reactions • Account for 20% of all medication errors and up to 90% of administration errors • Impair efficacy of administered drugs or increase risk of side effects, even formation of toxic compounds • on ICU, coinfusion of two drugs is uncertain in up to 45% of instances in which the compatibility of drug combination is unknown Taxis K, Barber N. Eur J Clin Pharmacol. 2004; 59: 815 – 7 Vogel Kahmann I. et al. Anaesthesist. 2003 52: 409 – 412 Kähny-Simonius J. Schweiz Rundsch Med Prax. 1993; 82:1320-7 Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine PD Dr. med. H. Bertram

  5. Origin of particles 2. Incomplete reconstitution of drugs or particles inherent to drug formulation • Generic formulations of antibiotics have been found to be heavily contaminated with particles • Parenteral nutrition admixtures: enlarged lipid droplets arise from emulsion instability and calcium phosphate precipitates occur 3. Arise from components of the infusion system (e.g. three way taps, roller pumps a.o.) Sendo T. et al. J Clin Pharmacy and Therapeutics. 2001; 26: 87 – 91 Driscoll DF et al. Clinical Nutrition. 2005; 24: 699-700 Lehr H.-A. et al. Am J Respir Crit Care Med. 2002; 165: 514–520 Driscoll DF et al Clinical Nutrition. 2006; 25(5): 842-50 Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine PD Dr. med. H. Bertram

  6. Origin of particlesAggravating factors for particle formation • Quantity of administered drugs and complexity of infusion regimen [1,2] • Lack of available intravenous lines [3] • Lack of incompatibility information for administered drugs or their formulation [3] [1]Jack & Brent et al. Intensive Care Med (2010) 36:707–711 [2] Mehrkens HH. Klin Anasthesiol Intensivther. 1977 (14):106-13. [3] Schroder F. Infusionsther Transfusionsmed 1994; 21: 52-58 Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine PD Dr. med. H. Bertram

  7. Electron microscopy of used in-line filters • 20 Filters of different patients were examined after 72 hours use on our PICU • Average number of particles found on the surface of the membrane was 542/cm2. • More than 20% of the examined filters showed signs of beginning blockage by particles retaintion Jack and Brent et al.; Intensive Care Med. (2010)

  8. Electrone microscopy 70%of the demonstarted particles were larger than a pulmonary capillary Particles from a filter membrane after 72 hours use in a 17 yaer old girl after aortic valve replacemant. [1] In-line filtration prevents intravascular infusion of "knife blades" and "spearheads" after open heart surgery. Brent B, Jack T, Sasse M; Eur Heart J. 2007 May; 28(10)

  9. Particulate contamination retained on filter membranesPrecipitation leads to blockage Parenteral nutrition with high osmolarity, 5ml/h, analysis of filter membrane after 72 hours in use

  10. Particulate contamination retained on filter membranesDependence on complexity of infusion regimen particle load / cm2 applied components via filter membrane Jack and Brent et al.; Intensive Care Med. (2010) Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  11. Clinical Data about the influence of intravenous particles Deleterious effects of particles on microperfusion in different organ systems after ischemia and reperfusion (Lehr et al. 2002 and 2008; Walpot et al. 1989) Reduction of thrombophlebitis after elimination of particles with infusion filters (Falchuk et al. 1985; Chee und Tan 2002) Increase of typical neonatal complications like inflammation, sepsis and enterocolitis (van Lingen et al. 2004) Chee S& Tan W (2002: Reducing Infusion Phlebitis in Singapore Hospitals Using Extended Life End-Line Filters. Journal of Infusion Nursing Vol 25, No 2:95-104. Falchuk KH, Peterson l, McNeil BJ (1985): Microparticulate-induces Phlebitis. Ist prevention by in-line filtration. NEJM, Jan 10; 312(2):78-82 Van Lingen RA, Baerts W, Marquering ACM, Ruijs GJHM (2004): The use of in-line filtration in sick newborn infants. Acta paedirtica 93; 1-5 Lehr HA, Br unner J, Rangoonwala R, Kirkpatrick CJ (2002) Particulate Matter Contamination of Intravenous Antibiotics Aggravates Loss of Functional Capillary Density in Postischemic Striated Muscle. Am. J. Resp. Crit. Care Med Volume 165. Number 4. February: 514-520. Walpot H, Franke RP, Burchard WG, Agternkamp, Mueller FG, Mittermayer Ch, Kalff G (1989)Particulate contamination of infusion solutions and drug additives during long-trem intensiv care (Part 2-Animal model). Anaesthesist 38: 617-621.

  12. The use of in-line intravenous filters in sick newborn infants van Lingen RA, Baerts W, Marquering ACM, Ruijs GJHM: The use of in-line intravenous filters in sick newborn infants. Acta Paediatr. 2004 93; 1-5.

  13. Prospective, randomized clinical trial for the use of In-line filtration in critically ill childrenStudy design • Prior to the study: Optimization of infusion regimen to prevent precipitation and incompatibilities of drugs and solutions • Randomization of pediatric intensive care patients to either control or interventional group • Interventional group receiving in-line infusion filters throughout complete infusion therapy (all solutions and medications), open label • Primary endpoints: Reduction in incidence of severe defined complications (SIRS, sepsis organ failure, mortality and thrombosis), study was powered (80%) for a reduction in the overall complication rate Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  14. Comprehensive view – Infusion setup Hannover Medical School Central venous catheter (3 lumen) for parenteral nutrition and catecholamine therapy following/change AA CH Lipid catech. 1 optional syringe pump optional syringe pump following/change catech. 2 optional following/change catech. 3 heparinization jugulas vein right / left Heparin basic iv-solution subclavian vein right / left CVP measurement short infusion optional bolus application volume replacement Clonidin Propofol Midazolam sedation femoral vein right / left Fentanyl Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  15. Prospective, randomized clinical trial for the use of In-line filtration in critically ill children • Gaussian distribution of patients to both groups (406 non-filter vs. 401 filter) • No differences in PIM II score, median age, weight or gender distribution • Heterogeneous background of disease with no significant differences in filter vs. control group Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  16. p=0,003 Primary outcome: Complication ratio and Mortality: Filter vs non-Filter group (n= 807) Jack T & Boehne M, et al. Intensive Care Med (2012) 38:1008–1016 p=0,093

  17. Significant reduction in incidence of SIRS in the filter group (123 non-filter group vs. 90 filter group; 95% CI, p<0.01) Jack T & Boehne M, et al. Intensive Care Med (2012) 38:1008–1016 Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine PD Dr. med. H. Bertram

  18. Results: Hazard Ratios of primary Endpoints and Mortality Jack T & Boehne M, et al. Intensive Care Med (2012) 38:1008–1016

  19. Minutes P=0,028 Length of stay on PICU Length of mechanical j ventilationjjjj Jack T & Boehne M, et al. Intensive Care Med (2012) 38:1008–1016

  20. Organ dysfunctions (IPSCC 2005): non-Filter Filter * * P<0,05 * * Boehne M & Jack T, et al. unpublished data, under review

  21. Summary • Particulate contamination of infusion solutions are not a threat, but represent an additional risk for intensive care patients • Particles seem to influence immune reaction • SIRS, Length of stay and length of MV was significantly reduced in the interventional group by the use of in-line filtration • Therefore ifiltration offers a new therapeutic option to reduce complications on ICU • Ongoing analyses focus on subgroups and economic aspects of filter use Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

  22. Thank you for your attention Members of the study group Martin Boehne MD Bernadette Brent MD Michael Sasse MD Johann Wessels Michaela Abura Verena Quartier Markus Becker Dilek Yilmaz Meike Müller PhD Katharina Seewald PhD Armin Braun PhD Armin Wessel MD, PhD Pediatric and Adolescent Medicine Dept. of Pediatric Cardiology and Intensive Care Medicine Prof. Dr. med. A. Wessel

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