Trial Outcomes & Findings for Ventilator-induced Lung Injury Vortex in Patients With SARS-CoV-2 (NCT NCT04174313)

NCT ID: NCT04174313

Last Updated: 2021-08-30

Results Overview

The number of patients who died and survived was compared between patients with SARS-CoV-2 who progressed with VILI VORTEX and without VILI VORTEX)

• Recruitment status: COMPLETED
• Target enrollment: 65 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2021-08-30

Participant Flow

Patients were recruited between March 2020 to March 2021

No patients with SARS-CoV-2 were excluded from the study prior to group assignment.

Participant milestones

Measure	VILI VORTEX Clinical categorization of patients with SARS-CoV-2 with VILI vortex	NO VILI VORTEX Clinical categorization of patients with SARS-CoV-2 without VILI vortex
Overall Study STARTED	15	50
Overall Study COMPLETED	15	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ventilator-induced Lung Injury Vortex in Patients With SARS-CoV-2

Baseline characteristics by cohort

Measure	VILI VORTEX n=15 Participants Participants who evolved with VILI vortex clinical criteria	No VILI VORTEX n=50 Participants Participants who evolved without clinical criteria for VILI vortex	Total n=65 Participants Total of all reporting groups
Age, Continuous	59 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Percentage of male and female patients · Female	6 Participants n=5 Participants	18 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Percentage of male and female patients · Male	9 Participants n=5 Participants	32 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	50 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Argentina	15 participants n=5 Participants	50 participants n=7 Participants	65 participants n=5 Participants
Comorbidities Hypertension	9 participants n=5 Participants	25 participants n=7 Participants	34 participants n=5 Participants
Comorbidities Diabetes Mellitus	25 participants n=5 Participants	33 participants n=7 Participants	58 participants n=5 Participants
Comorbidities Obesity	5 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants
Comorbidities Ischemic heart disease	2 participants n=5 Participants	6 participants n=7 Participants	8 participants n=5 Participants
Comorbidities COPD	3 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants
Comorbidities Cancer/immunosupresion	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: The evolution of the patients was compared with Chi square, significant p \<0.05

The number of patients who died and survived was compared between patients with SARS-CoV-2 who progressed with VILI VORTEX and without VILI VORTEX)

Outcome measures

Measure	VILI VORTEX n=15 Participants Patients who evolved with clinical criteria of VILI VORTEX	No VILI VORTEX n=50 Participants Patients who evolved without clinical criteria of VILI VORTEX
Number of Participants Who Survived and Died Survivors	1 Participants	31 Participants
Number of Participants Who Survived and Died Dead	14 Participants	19 Participants

PRIMARY outcome

Timeframe: 90 days

Population: The baseline characteristics of the population were similar for both groups.

The number of patients that evolved with refractory hypoxemia was compared between the patients with SARS-CoV-2 that evolved with VILI VORTEX and without VILI VORTEX) Refractory hypoxemia was defined as PaO2/FiO2 <100 despite the optimization of mechanical ventilation and prone positioning.

Outcome measures

Measure	VILI VORTEX n=50 Participants Patients who evolved with clinical criteria of VILI VORTEX	No VILI VORTEX n=15 Participants Patients who evolved without clinical criteria of VILI VORTEX
Number of Patients With and Without Refractory Hypoxemia no refractory hypoxemia	49 participants	1 participants
Number of Patients With and Without Refractory Hypoxemia with refractory hypoxemia	1 participants	14 participants

PRIMARY outcome

Timeframe: 90 days

The following variables and complications were also observed during the period of analysis: incidence of pneumonia associated with mechanical ventilation, need for noradrenaline over 0.1 γ/kg/min for more than 24 h, positive blood cultures, accumulated fluid balance, dialysis treatment, clinical and/or echocardiographic evidence of heart failure, lactate ≥2 mmol/L in at least two consecutive samples, presence of persistent fever (≥38º at least once a day for three consecutive days), and the highest value of ferritin, D-dimer, C-reactive protein, troponin I and LDH obtained during the first 14 days of invasive mechanical ventilation.

VILI vortex patients had positive blood cultures, moderate to severe shock, persistent fever and fluid balance was considerably more positive.

Outcome measures

Measure	VILI VORTEX n=15 Participants Patients who evolved with clinical criteria of VILI VORTEX	No VILI VORTEX n=50 Participants Patients who evolved without clinical criteria of VILI VORTEX
Number of Patients With Complications Bood cultures	9 Participants	10 Participants
Number of Patients With Complications intranosocomial pneumonia	7 Participants	19 Participants
Number of Patients With Complications Renal replacement therapy	7 Participants	18 Participants
Number of Patients With Complications Persistent fever	7 Participants	10 Participants

Adverse Events

VILI VORTEX

Serious events: 14 serious events

Other events: 10 other events

Deaths: 14 deaths

NO VILI VORTEX

Serious events: 23 serious events

Other events: 20 other events

Deaths: 19 deaths

Serious adverse events

Measure	VILI VORTEX n=15 participants at risk SARS-CoV-2 patients who evolved with VILI VORTEX	NO VILI VORTEX n=50 participants at risk SARS-CoV-2 patients who evolved without VILI VORTEX
Respiratory, thoracic and mediastinal disorders Refractory hipoxemy	93.3% 14/15 • Number of events 14 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.	2.0% 1/50 • Number of events 1 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.
Renal and urinary disorders Severe Kidney Failure	46.7% 7/15 • Number of events 7 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.	36.0% 18/50 • Number of events 18 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.
Infections and infestations Intranosocomial pneumonia	46.7% 7/15 • Number of events 7 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.	38.0% 19/50 • Number of events 19 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.
Infections and infestations Blood cultures	60.0% 9/15 • Number of events 9 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.	20.0% 10/50 • Number of events 10 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.

Other adverse events

Measure	VILI VORTEX n=15 participants at risk SARS-CoV-2 patients who evolved with VILI VORTEX	NO VILI VORTEX n=50 participants at risk SARS-CoV-2 patients who evolved without VILI VORTEX
Vascular disorders Lactate level >2mmol/L	46.7% 7/15 • Number of events 7 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.	32.0% 16/50 • Number of events 16 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.
General disorders Persistent fever	46.7% 7/15 • Number of events 7 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.	20.0% 10/50 • Number of events 10 • up to 12 weeks after entering the study Refractory hypoxemia was defined as PaO2/FiO2 \<100 despite the optimization of mechanical ventilation and prone positioning.

Additional Information

Nestor Pistillo

Hospital El Cruce

Phone: 054 1142109000

Email: npistillo@yahoo.com.ar

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place