AdultIVNICTUSNCT01915719
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.
A study testing Early non invasive ventilation and Oxygen therapy only in people with Adult and Acute Respiratory Failure Admitted in ICU, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Adult, Acute Respiratory Failure Admitted in ICU, Immuno Compromized
- What is being tested?
- Early non invasive ventilation and Oxygen therapy only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Feb 2016
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- ICU admission
- Acute respiratory failure defined by (PaO2<60 mmHg at room air) or (polypnea >30/min or dyspnea at rest) or respiratory distress. Since less than 72 hours.
- Immuno compromized patient defined by solid tumor (treated since less than 5 years) or haematological malignancy (treated since less than 5 years) or Solid organ transplantation or Stem cell transplantation or Immunosuppressive treatment (steroid > 1mg/kg/d or >1 month or other immunosuppressive treatment >1 month)
Who cannot join
- Hypercapnia >50 mmHg or increased of hypercapnia >10 mmHg under Oxygen treatment
- Need of immediate mechanical ventilation
- Obvious cardiogenic oedema
- Vasopressor use >0.03 µg/kg/min
- Glasgow Score <13
- End of life decision
Show all 10Show fewer
- Acute myocardial infarction
- Patient refusal
- Pregnancy
- No national health insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure
- Being tested
- Early non invasive ventilation, Oxygen therapy only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early non invasive ventilationProcedure or surgery
Oxygen therapy onlyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early non invasive ventilation | Experimental | Early non invasive ventilation Receives: Procedure: Early non invasive ventilation |
| Oxygen therapy only | Active comparator | Oxygen therapy only Receives: Procedure: Oxygen therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 28 Mortality
Measured: Day 28
Secondary outcomes (5)
Needs of mechanical ventilation
Measured: Day 28
SOFA Score
Measured: Hour 72
Nosocomial infection
Measured: day 28
Length of stay in ICU
Measured: Day 28
performance status (OMS scale ranging from 0-perfect status- to 4-moribund)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie lemiale, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915719
- Sponsor's protocol ID
- IVNICTUS
- Acronym
- IVNICTUS
- Status last verified
- Nov 2015
- First submitted
- 26 Jul 2013
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie. Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. Trials. 2014 Sep 25;15:372. doi: 10.1186/1745-6215-15-372.
PubMed 25257210Lemiale V, Mokart D, Resche-Rigon M, Pene F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Theodose I, Benoit D, Canet E, Barbier F, Rabbat A, Bruneel F, Vincent F, Klouche K, Loay K, Mariotte E, Bouadma L, Moreau AS, Seguin A, Meert AP, Reignier J, Papazian L, Mehzari I, Cohen Y, Schenck M, Hamidfar R, Darmon M, Demoule A, Chevret S, Azoulay E; Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie (GRRR-OH). Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1711-9. doi: 10.1001/jama.2015.12402.
PubMed 26444879
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01915719
- Acronym / sponsor ID
- IVNICTUS / IVNICTUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Aug 2013 (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.
Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early non invasive ventilation | Experimental | Procedure: Early non invasive ventilationEarly non invasive ventilation |
| Oxygen therapy only | Active comparator | Procedure: Oxygen therapy onlyOxygen therapy only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years old
- ICU admission
- Acute respiratory failure defined by (PaO2<60 mmHg at room air) or (polypnea >30/min or dyspnea at rest) or respiratory distress. Since less than 72 hours.
- Immuno compromized patient defined by solid tumor (treated since less than 5 years) or haematological malignancy (treated since less than 5 years) or Solid organ transplantation or Stem cell transplantation or Immunosuppressive treatment (steroid > 1mg/kg/d or >1 month or other immunosuppressive treatment >1 month)
Key exclusion criteria (10 listed)
- Hypercapnia >50 mmHg or increased of hypercapnia >10 mmHg under Oxygen treatment
- Need of immediate mechanical ventilation
- Obvious cardiogenic oedema
- Vasopressor use >0.03 µg/kg/min
- Glasgow Score <13
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 |
|---|---|---|
| Early non invasive ventilation | Procedure or surgery | Early non invasive ventilation |
| Oxygen therapy only | Procedure or surgery | Oxygen therapy only |
Primary outcome
Day 28 Mortality
Time frame: Day 28
5 secondary outcomes
Needs of mechanical ventilation
Time frame: Day 28
SOFA Score
Time frame: Hour 72
Nosocomial infection
Time frame: day 28
Length of stay in ICU
Time frame: Day 28
performance status (OMS scale ranging from 0-perfect status- to 4-moribund)
Time frame: 6 Months
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 18 Apr 2016.
- Background: PubMed 25257210Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie. Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. Trials. 2014 Sep 25;15:372. doi: 10.1186/1745-6215-15-372.
- Results publication: PubMed 26444879Lemiale V, Mokart D, Resche-Rigon M, Pene F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Theodose I, Benoit D, Canet E, Barbier F, Rabbat A, Bruneel F, Vincent F, Klouche K, Loay K, Mariotte E, Bouadma L, Moreau AS, Seguin A, Meert AP, Reignier J, Papazian L, Mehzari I, Cohen Y, Schenck M, Hamidfar R, Darmon M, Demoule A, Chevret S, Azoulay E; Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie (GRRR-OH). Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1711-9. doi: 10.1001/jama.2015.12402.
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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.
Virginie lemiale, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early non invasive ventilation and Oxygen therapy only in people with Adult and Acute Respiratory Failure Admitted in ICU, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 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 18 Apr 2016. 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 France. 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.
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?
Day 28 Mortality (time frame: Day 28). 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 NCT01915719, which also lists 2 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 18 Apr 2016.