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
1 other identifier
interventional
821
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 1, 2008
September 1, 2008
3.6 years
September 13, 2005
November 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Sepsis
Thrombosis
SIRS
Organ failure
Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"
Secondary Outcomes (2)
Duration of Pediatric Intensive Care Unit stay
Duration of overall hospital stay
Interventions
Eligibility Criteria
You may qualify if:
- Children admitted to pediatric intensive care unit (PICU)
You may not qualify if:
- Suspected death within 48 hours
- Duration of PICU stay less than 6 hours
- Patients recruited for Simulect or Sintra Study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- Pall Corporationcollaborator
- B. Braun Melsungen AGcollaborator
Study Sites (1)
Hannover Medical School
Hanover, Lower Saxony, 30625, Germany
Related Publications (3)
Lamping F, Jack T, Rubsamen N, Sasse M, Beerbaum P, Mikolajczyk RT, Boehne M, Karch A. Development and validation of a diagnostic model for early differentiation of sepsis and non-infectious SIRS in critically ill children - a data-driven approach using machine-learning algorithms. BMC Pediatr. 2018 Mar 15;18(1):112. doi: 10.1186/s12887-018-1082-2.
PMID: 29544449DERIVEDBoehne M, Jack T, Koditz H, Seidemann K, Schmidt F, Abura M, Bertram H, Sasse M. In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial. BMC Pediatr. 2013 Feb 6;13:21. doi: 10.1186/1471-2431-13-21.
PMID: 23384207DERIVEDJack 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.
PMID: 22527062DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Sasse, Consultant
Medical School Hannover
- PRINCIPAL INVESTIGATOR
Thomas Jack, Doctor
Medical School Hannover
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
February 1, 2005
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 1, 2008
Record last verified: 2008-09