Use of In-Line Filtration in Critically Ill Children

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209768
• Other study ID #: 3702
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 28, 2008
• Start date: February 2005
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 821
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Filter: NOE96E, ELD96E, NLF1E, TNA1E

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Niedersachsen

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	B. Braun Melsungen AG, Pall GmbH Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sepsis
Primary	Thrombosis
Primary	SIRS
Primary	Organ failure
Primary	Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"
Secondary	Duration of Pediatric Intensive Care Unit stay
Secondary	Duration of overall hospital stay