Clinical trial NCT02983851: Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
Official title: Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immunocompromised Patients
Acute Respiratory Failure
Keywords: Noninvasive mechanical ventilation
Invasive mechanical ventilation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
name: Ministry of Health, China
name: Fujian Provincial Hospital
name: First Affiliated Hospital of Kunming Medical University
name: First Affiliated Hospital, Sun Yat-Sen University
name: Renmin Hospital of Wuhan University
name: The First Affiliated Hospital of Zhengzhou University
name: The First Affiliated Hospital with Nanjing Medical University
name: The Second Hospital of Hebei Medical University
name: The First Affiliated Hospital of Anhui Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: General Hospital of Ningxia Medical University
name: Tianjin Medical University General Hospital
name: Second Xiangya Hospital of Central South University
name: The Second Affiliated Hospital of Harbin Medical University
name: Cangzhou Central Hospital
name: Handan First Hospital
First posted: 2016-12-06
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. 30 mmHg \< PaO2 \< 50 mmHg on room air;
  2. 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:

  1. HIV infection;
  2. Hematologic malignancy or solid tumor under chemotherapy;
  3. Solid organ or stem cell transplant;
  4. Long-term (\>30 days) or high dose steroids (\>1 mg/kg/d prednisone equivalent) usage and/or any other immunosuppressive drugs;
  5. Neutropenia (defined as a neutrocyte count of \< 0.50×109/L) showing for at least 48 hours

Exclusion Criteria:

* 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

Primary outcomes:
measure: 30-day all-cause mortality
timeFrame: the 30th day after patient inclusion in the study
Secondary outcomes:
measure: In-hospital mortality
timeFrame: through study study completion, an average of 2 years
measure: Length of stay in hospital
timeFrame: through study study completion, an average of 2 years
measure: Length of mechanical ventilation
timeFrame: through study study completion, an average of 2 years
measure: Nosocomial infections
timeFrame: through study study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: PUMC hospital,Chinese Academy of Medical Sciences
name: Yi Li, M.D.
role: STUDY_CHAIR
References:
citation: 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.