Catheter Complications Clinical Trial
— INCASOfficial title:
Central Lines Filtration in Newborns: a Multicenter Randomized Controlled Trial
NCT number | NCT05537389 |
Other study ID # | INCAS |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | October 1, 2024 |
Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU). In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in neonates, remain to be demonstrated. In-line filters in the intravenous administration sets prevent the infusion of particles, which may reduce infectious complications.
Status | Recruiting |
Enrollment | 736 |
Est. completion date | October 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Hour to 3 Months |
Eligibility | Inclusion Criteria: - All patients admitted to NICU with at least one central venous catheter Exclusion Criteria: - Patients with peripheral venous catheter, patients with inflammatory episode at the time of enrollment |
Country | Name | City | State |
---|---|---|---|
Italy | Città della Salute e della Scienza | Torino | Italia |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy | Pall Corporation |
Italy,
Eschborn S, Weitkamp JH. Procalcitonin versus C-reactive protein: review of kinetics and performance for diagnosis of neonatal sepsis. J Perinatol. 2019 Jul;39(7):893-903. doi: 10.1038/s41372-019-0363-4. Epub 2019 Mar 29. — View Citation
Foster JP, Richards R, Showell MG, Jones LJ. Intravenous in-line filters for preventing morbidity and mortality in neonates. Cochrane Database Syst Rev. 2015 Aug 6;2015(8):CD005248. doi: 10.1002/14651858.CD005248.pub3. — View Citation
Jack T, Boehne M, Brent BE, Hoy L, Koditz H, Wessel A, Sasse M. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med. 2012 Jun;38(6):1008-16. doi: 10.1007/s00134-012-2539-7. Epub 2012 Apr 12. — View Citation
Sasse M, Dziuba F, Jack T, Koditz H, Kaussen T, Bertram H, Beerbaum P, Boehne M. In-line Filtration Decreases Systemic Inflammatory Response Syndrome, Renal and Hematologic Dysfunction in Pediatric Cardiac Intensive Care Patients. Pediatr Cardiol. 2015 Aug;36(6):1270-8. doi: 10.1007/s00246-015-1157-x. Epub 2015 Apr 7. — View Citation
van den Hoogen A, Krediet TG, Uiterwaal CS, Bolenius JF, Gerards LJ, Fleer A. In-line filters in central venous catheters in a neonatal intensive care unit. J Perinat Med. 2006;34(1):71-4. doi: 10.1515/JPM.2006.009. — View Citation
van Lingen RA, Baerts W, Marquering AC, Ruijs GJ. The use of in-line intravenous filters in sick newborn infants. Acta Paediatr. 2004 May;93(5):658-62. doi: 10.1111/j.1651-2227.2004.tb02993.x. — View Citation
Virlouvet AL, Pansiot J, Toumazi A, Colella M, Capewell A, Guerriero E, Storme T, Rioualen S, Bourmaud A, Biran V, Baud O. In-line filtration in very preterm neonates: a randomized controlled trial. Sci Rep. 2020 Mar 19;10(1):5003. doi: 10.1038/s41598-020-61815-4. — View Citation
Worthington P, Gura KM, Kraft MD, Nishikawa R, Guenter P, Sacks GS; ASPEN PN Safety Committee. Update on the Use of Filters for Parenteral Nutrition: An ASPEN Position Paper. Nutr Clin Pract. 2021 Feb;36(1):29-39. doi: 10.1002/ncp.10587. Epub 2020 Oct 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of patients with at least one inflammatory episode sepsis-like. | Frequency of patients with at least one inflammatory episode sepsis-like, defined by alteration of the biomarkers of inflammation in a negative-culture contest. | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months | |
Secondary | Frequency of patients with at least one episode of sepsis. | Frequency of patients with at least one inflammatory episode defined by alteration of the biomarkers of inflammation in a positive-culture contest. | From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months |
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