BridgeMD
New treatment option for Respiratory Distress Syndrome, Adult
Official title Trial of Therapeutic Hypothermia in Patients With ARDS
ClinicalTrials.gov ID: NCT04545424
What this study is testing
What is Neuromuscular Blocking Agents?
Neuromuscular Blocking Agents is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for respiratory distress syndrome, adult.
Also referred to as Paralytics.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of \~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days;
- admitted to a participating ICU
- radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural effusions, atelectasis, or hydrostatic pulmonary edema
- P/F ratio ≤200 with PEEP ≥8 cm H2O; If ABG values are not available, the P/F ratio may be inferred from SpO2 values based on Table 3 from Brown et al...
- SpO2 values are 80-96%
You likely can't join if
- Missed moderate-severe ARDS window (\>72hrs) - Window starts when patient is intubated with a qualifying P/F ratio of ≤ 200 with PEEP ≥ 8 cm H2O or...
- Missed NMB window: (\>48 hrs)
- Missed mechanical ventilation window (\>7 days)
- Refractory hypotension (continuous infusion of \>0.3 mcg/kg/min of norepinephrine or equivalent dose of other vasopressors within 2 hours prior to...
- Core temperature \<35°C for ≥6 hours while not receiving CRRT on day of randomization
- Significant, active bleeding (\>3u blood products and/or surgical/IR intervention) on day of randomization
See the full eligibility criteria
- endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days;
- admitted to a participating ICU
- radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural effusions, atelectasis, or hydrostatic pulmonary edema
- P/F ratio ≤200 with PEEP ≥8 cm H2O; If ABG values are not available, the P/F ratio may be inferred from SpO2 values based on Table 3 from Brown et al as long as following conditions are met:
- SpO2 values are 80-96%
- SpO2 is measured ≥10 min after any change in FIO2
- PEEP is ≥ 8 cm H2O
- the pulse oximeter waveform tracing is adequate
- the qualifying inferred P/F ratio is confirmed 1-6h after initial determination.
- access to an LAR to provide consent.
- Criteria 3 AND 4 must be met within 72h of enrollment and randomization, not be fully explained by hydrostatic pulmonary edema, and must have occurred within 7 days of exposure to an ARDS-risk factor (including...
- Patients may be enrolled and decision about randomization delayed if all criteria other than P/F ratio ≤ 200 are met and then assigned by chance if and when the P/F ratio ≤200 (as long as this occurs within 72h of...
- Missed moderate-severe ARDS window (\>72hrs) - Window starts when patient is intubated with a qualifying P/F ratio of ≤ 200 with PEEP ≥ 8 cm H2O or on high flow nasal oxygen with well-fitting nasal cannula with flow ≥...
- Missed NMB window: (\>48 hrs)
- Missed mechanical ventilation window (\>7 days)
- Refractory hypotension (continuous infusion of \>0.3 mcg/kg/min of norepinephrine or equivalent dose of other vasopressors within 2 hours prior to randomization)
- Core temperature \<35°C for ≥6 hours while not receiving CRRT on day of randomization
- Significant, active bleeding (\>3u blood products and/or surgical/IR intervention) on day of randomization
- Platelets \<10K/mm3 (uncorrected) on day of randomization
- Active hematologic malignancy and not expected to survive 6 months
- Skin process that precludes cooling device
- Moribund, not likely to survive 72h
- Pre-morbid condition makes it unlikely that patient will survive 28 days
- Do Not Resuscitate status at time of randomization (excluding patients receiving full support EXCEPT CPR for cardiac arrest)
- Not likely to remain intubated for ≥48h
- Physician of record unwilling to participate
- Severe underlying lung disease
- Needs \> 2 LPM or \>28% continuous home O2 (adjusted for altitude)
- On BIPAP (except for OSA)
- Prior lung transplantation
- Pregnant at time of randomization
- BMI consistently \>50 kg/m2
- Known NYHA class IV heart disease
- Acute Coronary Syndrome (MI, unstable angina) within 30 days of randomization
- Cardiac arrest within 30 days of randomization with sequelae likely to increase mortality and/or time to ventilator liberation.
- Burns over \>20% of the body surface
- Severe chronic liver disease (Child-Pugh score 12-15)
- Previously assigned by chance in CHILL study
- Simultaneous enrollment in another inpatient treatment trial started during the current hospitalization.
- On ECMO during the current hospitalization.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- Camden, New Jersey, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Fort Sam Houston, Texas, United States
- Salt Lake City, Utah, United States
- Madison, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; New Haven, Connecticut, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Lexington, Kentucky, United States; Baltimore, Maryland, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.