Critical IllnessPhase 4NCT00209768
Use of In-Line Filtration in Critically Ill Children
A Phase 4 study testing Filter: NOE96E, ELD96E, NLF1E, TNA1E in people with Critical Illness, run by Hannover Medical School at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Filter: NOE96E, ELD96E, NLF1E, TNA1E
- Type of treatment
- Medical device
- How many people
- 821 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2005to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children admitted to pediatric intensive care unit (PICU)
Who cannot join
- Suspected death within 48 hours
- Duration of PICU stay less than 6 hours
- Patients recruited for Simulect or Sintra Study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children
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).
Read the 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
- Lung
- Kidney
- Liver
- Circulation
- Conditions
- Critical Illness
- Being tested
- Filter: NOE96E, ELD96E, NLF1E, TNA1E
- Keywords
- pediatric intensive care, critically ill children, in-line filtration, prospective randomized study, complications, sepsis, SIRS, thrombosis, organ failure
- Medical subject headings
- Critical Illness, Sepsis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filter: NOE96E, ELD96E, NLF1E, TNA1EDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Pall Corporation, B. Braun Melsungen AG
- Investigators
- Michael Sasse, Consultant, Study director, Medical School HannoverThomas Jack, Doctor, Principal investigator, Medical School Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209768
- Sponsor's protocol ID
- 3702
- Status last verified
- Sep 2008
- First submitted
- 13 Sep 2005
- Last updated
- 1 Dec 2008
- Results posted
- No
Publications
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.
PubMed 29544449Boehne 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.
PubMed 23384207Jack 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.
PubMed 22527062
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Prospective Study of the Use of In-Line Filtration on the Reduction of Complication Rate in Critically Ill Children
- ClinicalTrials.gov ID
- NCT00209768
- Acronym / sponsor ID
- 3702
- Conditions
- Critical Illness
- Keywords
- pediatric intensive care, critically ill children, in-line filtration, prospective randomized study, complications, sepsis, SIRS, thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 821 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Pall Corporation, B. Braun Melsungen AG
- Study start
- Feb 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Lung
- Kidney
- Liver
- Circulation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children admitted to pediatric intensive care unit (PICU)
Key exclusion criteria (3 listed)
- Suspected death within 48 hours
- Duration of PICU stay less than 6 hours
- Patients recruited for Simulect or Sintra Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filter: NOE96E, ELD96E, NLF1E, TNA1E | Device | – |
Primary outcome
Sepsis
Thrombosis
SIRS
Organ failure
Composite primary outcome including "sepsis, SIRS, thrombosis, organ failure"
2 secondary outcomes
Duration of Pediatric Intensive Care Unit stay
Duration of overall hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2008.
- Derived from this study: PubMed 29544449Lamping 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.
- Derived from this study: PubMed 23384207Boehne 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.
- Derived from this study: PubMed 22527062Jack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sasse, Consultant study director
Medical School Hannover
Thomas Jack, Doctor principal investigator
Medical School Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Filter: NOE96E, ELD96E, NLF1E, TNA1E in people with Critical Illness, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00209768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2008.