Immunocompromised PatientsNCT02983851
Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
A study testing Noninvasive mechanical ventilation and Invasive mechanical ventilation in people with Immunocompromised Patients and Acute Respiratory Failure, run by Peking Union Medical College Hospital.
Trial summary
VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying the initial ventilation strategy for adult immunocompromised patients with acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immunocompromised Patients, Acute Respiratory Failure
- What is being tested?
- Noninvasive mechanical ventilation and Invasive mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years old ≤ age ≤ 80 years old) immunocompromised patients admitted to hospital with moderate to severe ARF diagnosed within the last 72 hours, which meets the indications for ventilatory support.
- Patients are considered as moderate to severe ARF when the ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) is between 85 and 170 while the patient is breathing oxygen through a Venturi mask, or clinically diagnosed as the following:
- 30 mmHg < PaO2 < 50 mmHg on room air;
- Clinical evidence of respiratory distress (intercostal recession, polypnea >35/min or dyspnea at rest).
- Patients are considered as immunocompromised when clinically diagnosed as at least one of the following:
- HIV infection;
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- Hematologic malignancy or solid tumor under chemotherapy;
- Solid organ or stem cell transplant;
- Long-term (>30 days) or high dose steroids (>1 mg/kg/d prednisone equivalent) usage and/or any other immunosuppressive drugs;
- Neutropenia (defined as a neutrocyte count of < 0.50×109/L) showing for at least 48 hours
Who cannot join
- Age<18 or >80 years old;
- Partial pressure of arterial carbon dioxide (PaCO2) > 50 mmHg or arterial pH < 7.20;
- PaO2/FiO2 >170 or PaO2/FiO2< 85;
- Patients have been treated with NIV or IMV within 30 days.
- NIV is contraindicated or IMV is definitely indicated, including PaO2/FiO2< 85, respiratory arrest, hemodynamic instability, inability to fit the face mask, pneumothorax, vomiting, development of airway bleeding, inability to protect the airway, or copious respiratory secretions;
- Comorbided with other severe diseases, including New York Heart Association functional class ≥ II, valvular heart disease, dilated cardiomyopathy, cardiogenic pulmonary edema, implanted cardiac pacemaker, unstable angina, myocardial infarction, or cardiac surgery within the previous 3 months; systolic arterial pressure <90 mmHg after optimal fluid therapy; history of chronic obstructive pulmonary disease (COPD) or asthma; impaired consciousness (Glasgow Coma Scale score <13); postoperative acute respiratory failure; pregnancy or breastfeeding;
- Lack of consent, do-not-intubate decision, and any other situations where obvious bias are expected
Trial locations and contacts
No sites are listed yet.
About this study
VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying the initial ventilation strategy for adult immunocompromised patients with acute respiratory failure.
Read the detailed description
The VENIM is a multicenter randomized controlled trial (RCT) comparing the effects of NIV compared with IMV in adult immunocompromised patients with moderate to severe acute respiratory failure (ARF). Patients who meet the indications for both ventilatory supports will be included. The intervention will consist of randomly allocation, treatment with NIV or IMV, concomitant medication. Primary outcome is 30-day hospital mortality. Secondary outcomes include in-hospital mortality, length of stay in hospital, improvement of oxygenation, nosocomial infections, seven-day organ failure, adverse events of intervention, et al. Subgroups with different disease severity, causes of immunodeficiency and types of ARF will also be analyzed.
- Being tested
- Noninvasive mechanical ventilation, Invasive mechanical ventilation
- Keywords
- Noninvasive mechanical ventilation, Invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive mechanical ventilationProcedure or surgery
Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.
Invasive mechanical ventilationProcedure or surgery
Invasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive mechanical ventilation | Experimental | Patients in this group will receive Noninvasive mechanical ventilation as the initial mechanical ventilation (MV) strategy, irrespective of whether Invasive mechanical ventilation is used later during the following treatment. Receives: Procedure: Noninvasive mechanical ventilation |
| Invasive mechanical ventilation | Active comparator | Patients in this group will receive Invasive mechanical ventilation as the initial MV strategy, irrespective of whether Noninvasive mechanical ventilation is used later during the following treatment. Receives: Procedure: Invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality
Measured: the 30th day after patient inclusion in the study
Secondary outcomes (4)
In-hospital mortality
Measured: through study study completion, an average of 2 years
Length of stay in hospital
Measured: through study study completion, an average of 2 years
Length of mechanical ventilation
Measured: through study study completion, an average of 2 years
Nosocomial infections
Measured: through study study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunocompromised PatientsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Ministry of Health, China, Fujian Provincial Hospital, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital, Sun Yat-Sen University, Renmin Hospital of Wuhan University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital of Inner Mongolia Medical University, General Hospital of Ningxia Medical University, Tianjin Medical University General Hospital, Second Xiangya Hospital of Central South University, The Second Affiliated Hospital of Harbin Medical University, Cangzhou Central Hospital, Handan First Hospital
- Responsible party
- Principal investigator, Yi Li, MD, Peking Union Medical College Hospital
- Investigators
- Yi Li, M.D., Study chair, PUMC hospital,Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983851
- Sponsor's protocol ID
- VENIM
- Status last verified
- Dec 2016
- First submitted
- 25 Nov 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wang T, Liu G, He K, Lu X, Liang X, Wang M, Zhu R, Li Z, Chen F, Ke J, Lin Q, Qian C, Li B, Wei J, Lv J, Li L, Gao Y, Wu G, Yu X, Wei W, Deng Y, Wang F, Zhang H, Zheng Y, Zhan H, Liao J, Tian Y, Yao D, Zhang J, Chen X, Yang L, Wu J, Chai Y, Shou S, Yu M, Xiang X, Zhang D, Chen F, Xie X, Li Y, Wang B, Zhang W, Miao Y, Eddleston M, He J, Ma Y, Xu S, Li Y, Zhu H, Yu X. The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM). BMC Pulm Med. 2017 Sep 20;17(1):127. doi: 10.1186/s12890-017-0467-6.
PubMed 28931394
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT02983851
- Acronym / sponsor ID
- VENIM
- Keywords
- Noninvasive mechanical ventilation, Invasive mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Ministry of Health, China, Fujian Provincial Hospital, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital, Sun Yat-Sen University, Renmin Hospital of Wuhan University, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Anhui Medical University, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital of Inner Mongolia Medical University, General Hospital of Ningxia Medical University, Tianjin Medical University General Hospital, Second Xiangya Hospital of Central South University, The Second Affiliated Hospital of Harbin Medical University, Cangzhou Central Hospital, Handan First Hospital
- Study start
- Dec 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Dec 2016 (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.
VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying the initial ventilation strategy for adult immunocompromised patients with acute respiratory failure.
Detailed description
The VENIM is a multicenter randomized controlled trial (RCT) comparing the effects of NIV compared with IMV in adult immunocompromised patients with moderate to severe acute respiratory failure (ARF). Patients who meet the indications for both ventilatory supports will be included. The intervention will consist of randomly allocation, treatment with NIV or IMV, concomitant medication. Primary outcome is 30-day hospital mortality. Secondary outcomes include in-hospital mortality, length of stay in hospital, improvement of oxygenation, nosocomial infections, seven-day organ failure, adverse events of intervention, et al. Subgroups with different disease severity, causes of immunodeficiency and types of ARF will also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive mechanical ventilation | Experimental | Procedure: Noninvasive mechanical ventilationPatients in this group will receive Noninvasive mechanical ventilation as the initial mechanical ventilation (MV) strategy, irrespective of whether Invasive mechanical ventilation is used later during the following treatment. |
| Invasive mechanical ventilation | Active comparator | Procedure: Invasive mechanical ventilationPatients in this group will receive Invasive mechanical ventilation as the initial MV strategy, irrespective of whether Noninvasive mechanical ventilation is used later during the following treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult (18 years old ≤ age ≤ 80 years old) immunocompromised patients admitted to hospital with moderate to severe ARF diagnosed within the last 72 hours, which meets the indications for ventilatory support.
- Patients are considered as moderate to severe ARF when the ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) is between 85 and 170 while the patient is breathing oxygen through a Venturi mask, or clinically diagnosed as the following:
- Patients are considered as immunocompromised when clinically diagnosed as at least one of the following:
Key exclusion criteria (7 listed)
- Age<18 or >80 years old;
- Partial pressure of arterial carbon dioxide (PaCO2) > 50 mmHg or arterial pH < 7.20;
- PaO2/FiO2 >170 or PaO2/FiO2< 85;
- Patients have been treated with NIV or IMV within 30 days.
- NIV is contraindicated or IMV is definitely indicated, including PaO2/FiO2< 85, respiratory arrest, hemodynamic instability, inability to fit the face mask, pneumothorax, vomiting, development of airway bleeding, inability to protect the airway, or copious respiratory secretions;
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 |
|---|---|---|
| Noninvasive mechanical ventilationNoninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system. | Procedure or surgery | Noninvasive mechanical ventilation |
| Invasive mechanical ventilationInvasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation. | Procedure or surgery | Invasive mechanical ventilation |
Primary outcome
30-day all-cause mortality
Time frame: the 30th day after patient inclusion in the study
4 secondary outcomes
In-hospital mortality
Time frame: through study study completion, an average of 2 years
Length of stay in hospital
Time frame: through study study completion, an average of 2 years
Length of mechanical ventilation
Time frame: through study study completion, an average of 2 years
Nosocomial infections
Time frame: through study study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Derived from this study: PubMed 28931394Wang T, Liu G, He K, Lu X, Liang X, Wang M, Zhu R, Li Z, Chen F, Ke J, Lin Q, Qian C, Li B, Wei J, Lv J, Li L, Gao Y, Wu G, Yu X, Wei W, Deng Y, Wang F, Zhang H, Zheng Y, Zhan H, Liao J, Tian Y, Yao D, Zhang J, Chen X, Yang L, Wu J, Chai Y, Shou S, Yu M, Xiang X, Zhang D, Chen F, Xie X, Li Y, Wang B, Zhang W, Miao Y, Eddleston M, He J, Ma Y, Xu S, Li Y, Zhu H, Yu X. The efficacy of initial ventilation strategy for adult immunocompromised patients with severe acute hypoxemic respiratory failure: study protocol for a multicentre randomized controlled trial (VENIM). BMC Pulm Med. 2017 Sep 20;17(1):127. doi: 10.1186/s12890-017-0467-6.
- Individual participant dataSharing planned: Undecided
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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.
Yi Li, M.D. study chair
PUMC hospital,Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive mechanical ventilation and Invasive mechanical ventilation in people with Immunocompromised Patients and Acute Respiratory Failure, run by Peking Union Medical College Hospital.
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 10 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Dec 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Li, M.D. (13693109826, billliyi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality (time frame: the 30th day after patient inclusion in the study). 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 NCT02983851, which also lists 1 linked publication.
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 6 Dec 2016.