Acute Lung InjuryPhase 1/2NCT00852605
Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment
A Phase 1/2 study testing Intermittent Non-Invasive Ventilation in people with Acute Lung Injury, run by Technische Universität Dresden.
Trial summary
Acute lung injury (ALI) is an early complication after allogeneic transplantation causing significant mortality and morbidity. Little is known on early markers and treatment of this complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- Intermittent Non-Invasive Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Aug 2005
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing allogeneic transplantation presenting with at least two of the following criteria
- Respiratory rate >25 / min
- Oxygenation Index <300
- Continuous oxygen-saturation <92% whilst breathing room air
Who cannot join
- Indication for Emergency intubation
- Hemodynamic instability
- Left ventricular failure
- GCS <8
- No consent
About this study
Official title: A Randomized Clinical Trial on the Use of Early Intermittent Non-Invasive Ventilation in Patients Suffering From Acute Lung Injury After Allogeneic Transplantation
Acute lung injury (ALI) is an early complication after allogeneic transplantation causing significant mortality and morbidity. Little is known on early markers and treatment of this complication. Recent data (Hilbert et al.) suggested a beneficial effect of Non-Invasive-Ventilation in ALI-patients immunosuppressed because a many different reasons including stem-cell transplantation.
The investigators study is designed to evaluate early markers of ALI after allogeneic transplantation. In case ALI is documented patients are randomized to either conventional therapy (oxygen-support) or conventional therapy plus intermittent Non-Invasive Ventilation. The hypothesis is that Non-Invasive Ventilation improves outcome of ALI after allogeneic transplantation.
- Conditions
- Acute Lung Injury
- Being tested
- Intermittent Non-Invasive Ventilation
- Keywords
- Acute Lung Injury after allogeneic transplantation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Non-Invasive VentilationOther
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | No intervention | Conventional Treatment including Oxygen-support |
| NIV | Experimental | Conventional Treatment plus intermittent Non-Invasive-Ventilation Receives: Other: Intermittent Non-Invasive Ventilation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startDec 2001
- Primary completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 1/2
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Illmer Thomas, Ph D, Principal investigator, Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852605
- Sponsor's protocol ID
- NIV2001
- Status last verified
- Feb 2009
- First submitted
- 26 Feb 2009
- Last updated
- 27 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on the Use of Early Intermittent Non-Invasive Ventilation in Patients Suffering From Acute Lung Injury After Allogeneic Transplantation
- ClinicalTrials.gov ID
- NCT00852605
- Acronym / sponsor ID
- NIV2001
- Conditions
- Acute Lung Injury
- Keywords
- Acute Lung Injury after allogeneic transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Dec 2001
- Primary completion
- Aug 2005 (actual)
- First posted
- 27 Feb 2009 (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.
Acute lung injury (ALI) is an early complication after allogeneic transplantation causing significant mortality and morbidity. Little is known on early markers and treatment of this complication. Recent data (Hilbert et al.) suggested a beneficial effect of Non-Invasive-Ventilation in ALI-patients immunosuppressed because a many different reasons including stem-cell transplantation.
The investigators study is designed to evaluate early markers of ALI after allogeneic transplantation. In case ALI is documented patients are randomized to either conventional therapy (oxygen-support) or conventional therapy plus intermittent Non-Invasive Ventilation. The hypothesis is that Non-Invasive Ventilation improves outcome of ALI after allogeneic transplantation.
Study design
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | No intervention | –Conventional Treatment including Oxygen-support |
| NIV | Experimental | Other: Intermittent Non-Invasive VentilationConventional Treatment plus intermittent Non-Invasive-Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing allogeneic transplantation presenting with at least two of the following criteria
- Respiratory rate >25 / min
- Oxygenation Index <300
- Continuous oxygen-saturation <92% whilst breathing room air
Key exclusion criteria (5 listed)
- Indication for Emergency intubation
- Hemodynamic instability
- Left ventricular failure
- GCS <8
- No consent
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 |
|---|---|---|
| Intermittent Non-Invasive Ventilation | Other | NIV |
Primary outcome
Not reported in the source record.
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 27 Feb 2009.
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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.
Illmer Thomas, Ph D principal investigator
Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intermittent Non-Invasive Ventilation in people with Acute Lung Injury, run by Technische Universität Dresden.
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 4 inclusion and 5 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 27 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
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 27 Feb 2009.