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Use of In-Line Filtration in Critically Ill Children

Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00209768
Enrollment
821
Registered
2005-09-21
Start date
2005-02-28
Completion date
2008-09-30
Last updated
2008-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

pediatric intensive care, critically ill children, in-line filtration, prospective randomized study, complications, sepsis, SIRS, thrombosis, organ failure

Brief summary

The purpose of this study is to determine whether the use of in-line filtration shows any effect on the outcome of sepsis, systemic inflammatory response syndrome (SIRS), thrombosis, or organ failure in critically ill children admitted to the pediatric intensive care unit (PICU).

Detailed description

Scientific background: Particulate contamination of infusion solutions and their systemic administration during infusion therapy has been linked to various clinical problems. Organ failure and Multi-Organ Failure (MOV): It is well established that the pathophysiology of MOV involves deteriorations of the microcirculation and integrity of endothelial cells. As a consequence of this an imbalance between pro- and anticoagulatory factors may develop and microthrombi may form. Mediators like tissue factor (TF) and platelet activating factor (PAF) have been linked to the formation of microthrombi. Particles have been discussed as a causative agent for this syndrome by various authors. Their effect on morbidity and mortality of patients has however not yet been established. Particles may have additional harmful effects: * Direct thrombogenesis by the particle material * Damaging endothelial cells in the capillary network * Embolisation of the pulmonary vasculature * Acting as a cristallisation focus for the development of granuloma * Promoting the formation of Giant Cells Various authors have shown that the use of end line infusion filters significantly reduces the rate of thrombophlebitis. A recently published study by van Lingen et al. (2004) also showed that the use of end line infusion filters significantly reduced the rate of overall complications in neonates. Study Hypothesis: The use of end line positively charged 0.2 µm and uncharged 1.2 µm infusion filters will prevent particles, microorganisms and their endotoxins from the infusate to enter the patient's circulation in the study group and will reduce significantly the complication rate of these patients. The following clinical diagnoses are defined as Complications. They are main contributors to morbidity and mortality in intensive care wards: * catheter related thrombosis of the central veins * sepsis with proven infectious organisms * Septic syndrome without proven infectious organisms * Failure of one of the following organs/systems 1. Lung 2. Kidney 3. Liver 4. Circulation

Interventions

DEVICEFilter: NOE96E, ELD96E, NLF1E, TNA1E

Sponsors

Pall Corporation
CollaboratorOTHER
B. Braun Melsungen AG
CollaboratorINDUSTRY
Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

* Children admitted to pediatric intensive care unit (PICU)

Exclusion criteria

* Suspected death within 48 hours * Duration of PICU stay less than 6 hours * Patients recruited for Simulect or Sintra Study

Design outcomes

Primary

MeasureTime frame
Thrombosis
Organ failure
Composite primary outcome including sepsis, SIRS, thrombosis, organ failure
Sepsis
SIRS

Secondary

MeasureTime frame
Duration of overall hospital stay
Duration of Pediatric Intensive Care Unit stay

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026