Critical Care Clinical Trials

ACTIV-3b: Accelerating COVID-19 Therapeutic Interventions and Vaccines

  • ClinicalTrials.gov: NCT04843761
  • Rationale: To evaluate efficacy of aviptadil and remdesivir for treating respiratory failure caused by COVID-19 in a multicenter randomized controlled trial. In this 2x2 factorial trial, participants are randomly assigned to receive aviptadil or placebo, and separately remdesivir or placebo, in addition to receiving current standard of care. The primary outcome is recovery through day 90.
  • Inclusion Criteria: ≥ 18 years old, acute respiratory failure due to COVID-19 + requiring either high flow nasal oxygen, non-invasive or invasive ventilation or ECMO.
  • Principal Investigator: Jeremy Beitler, MD, MPH
  • Recruiting: Yes
  • Contact: Alexis Serra als9220@nyp.org   

Blood Management During ECMO for Cardiac Support: OBLEX

  • ClinicalTrials.gov: NCT03714048
  • Rationale: This is an international, multicenter, prospective observational cohort study that aims to describe bleeding, thromboembolic complications, blood management and anticoagulation strategies in ECMO for mechanical circulatory support. This study seeks to identify risk factors for bleeding and thromboembolic complications as well as investigate any associations with morbidity and mortality.
  • Inclusion Criteria: All adult patients who receive extracorporeal lung support (ECMO) for mechanical circulatory support
  • Principal Investigator: Koji Takeda, MD
  • Trial Steering Committee Member: Daniel Brodie, MD
  • Recruiting: Yes
  • Contact: Alexis Serra als9220@nyp.org

Clinical performance of a novel PCR-based respiratory tract test (BioFire Pneumonia Panel)

  • Rationale: To understand whether the clinical utility of the BioFire Pneumonia Panel is maintained across different methods of specimen collection (BAL, mini-BAL, and tracheal aspirate). 
  • Inclusion Criteria: ≥ 18 years old, intubated or with tracheostomy, planned to undergo BAL for presumed pneumonia.
  • Principal Investigators: Fann Wu, MD, PhD, and Magdalena Sobieszczyk, MD
  • Recruiting: Yes 
  • Contact: Debbie Theodore dat2132@cumc.columbia.edu

FAST Trial: Frequency of Screening and SBT Technique Trial

  • ClinicalTrials.gov: NCT02969226
  • Rationale: To assess the best strategy for patients to be successfully weaned and removed from the ventilator. In this 2x2 factorial trial, participants are assigned to undergo a spontaneous breathing trial (SBT) once versus at least twice daily, to be performed via T-piece or pressure support. The primary outcome is time to successful extubation.
  • Inclusion Criteria: ≥ 18 years old, requiring mechanical ventilation for ≥ 24 hours, able to trigger a breath, FIO2 ≤ 70% and PEEP ≤ 12cmH2O.
  • Principal Investigator: Jeremy Beitler, MD, MPH
  • Recruiting: Yes
  • Contact: Ivan Garcia ig2361@cumc.columbia.edu

I-SPY COVID-19 Trial

  • ClinicalTrials.gov:​​​​​​​ NCT04488081
  • Rationale: To test promising candidate therapies for treatment of critically ill COVID-19 patients in a multicenter randomized controlled trial. As a phase 2 platform design, the trial employs a master protocol to enroll continuously, evaluating different therapies over time, so long as the need for novel therapeutics for severe COVID persists. Potential therapies will be evaluated for their ability to accelerate recovery (primary outcome) and improve survival from severe COVID-19.
  • Inclusion Criteria: ≥ 18 years old, COVID-19 +, requiring more than 6LPM of supplemental oxygen
  • Principal Investigator: Jeremy Beitler, MD, MPH
  • Recruiting: Yes
  • Contact: Alexis Serra als9220@nyp.org   

ICU Bioregistry

  • Rationale: To develop a critical illness bioregistry intended to facilitate comparative research in acute respiratory failure, sepsis and post-cardiac arrest syndrome, to identify final common pathways for multiple organ dysfunction syndrome (MODS).
  • Inclusion Criteria: ≥ 18 years old, with new sepsis or organ failure within 48 hours of ICU admission.
  • Principal Investigator: Jeremy Beitler, MD, MPH
  • Recruiting: Yes
  • Contact: Ivan Garcia ig2361@cumc.columbia.edu

INSPiRE-ICU2: Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients

  • Rationale: This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.
  • Inclusion Criteria: ≥ 18 years old; patients who are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU; and receipt of continuous sedation due to clinical need for sedation to RASS <0
  • Principal Investigator: Jeremy Beitler, MD, MPH
  • Recruiting: Not yet recruiting
  • Contact: Ivan Garcia ig2361@cumc.columbia.edu

Pharmacokinetics of piperacillin/tazobactam in adults undergoing extracorporeal membrane oxygenation 

  • Rationale: Changes in volume of distribution and clearance from critical illness and the ECMO circuit may affect pharmacodynamic parameters that ultimately determine the effectiveness of the antimicrobial agent. This study is aimed to quantify and describe the effect of ECMO.
  • Inclusion Criteria: ≥ 18 years old, on VV ECMO for acute respiratory distress syndrome, and receiving piperacillin/tazobactam
  • Principal Investigator: Daniel Brodie, MD
  • Recruiting: Yes
  • Contact:  Amy Dzierba ald9012@nyp.org

Prebiotic Inulin to Limit Antimicrobial-Resistant Infections During Critical Illness: A Phase 2 Clinical Trial

  • ClinicalTrials.gov:​​​​​​​​​​​​​​ NCT03865706
  • Rationale: To determine the feasibility and safety of inulin for the prevention of antibiotic resistant infections or colonization in critically ill patients. Outcomes include the change in relative abundance of fecal short-chain fatty acid-producing bacteria through ICU Day 3 and fecal multidrug-resistant organism colonization status on ICU Day 3.
  • Inclusion Criteria: ≥ 18 years old, in the ICU, diagnosed with sepsis and on antibiotics
  • Principal Investigator: Daniel Freedberg, MD
  • Recruiting: Yes
  • Contact: Elissa Lynch el2888@cumc.columbia.edu

PROMIS: PRevention Of Multiorgan Injury Syndrome

  • Rationale: To leverage the use of various forms of data to identify predictors of multiorgan failure and recovery from critical illness. This prospective observational cohort study of critically ill patients combining clinical chart data with analysis of ventilator waveforms and blood biomarkers to develop novel prediction models for risk of end-organ injury and likelihood of recovery as well as elucidate mechanisms of end-organ injury.
  • Inclusion Criteria: ≥ 18 years old, admitted to ICU or step-down unit with any of the following diagnoses: acute respiratory failure requiring 10 LPM or more of supplemental oxygen, shock requiring vasopressors, sepsis, and/or pre-hospital cardiac arrest.
  • Principal Investigator: Jeremy Beitler, MD, MPH
  • Recruiting: Yes
  • Contact: Alexis Serra als9220@nyp.org   

Prospective Multicenter Observational Study on Transfusion Practice in VV-ECMO: The PROTECMO Study

  • ClinicalTrials.gov:​​​​​​​​​​​​​​ NCT03815773
  • Rationale: This is an international, multicenter, prospective observational cohort study that aims to describe current transfusion practices during VV-ECMO for acute respiratory failure, as well as the current anticoagulation strategies and bleeding episode incidence in a large cohort of ECMO patients.
  • Inclusion Criteria: All adult patients who receive extracorporeal lung support (ECMO) for ARDS or respiratory causes
  • Principal Investigator: Cara Agerstrand, MD
  • Trial Steering Committee Member: Daniel Brodie, MD
  • Recruiting: No
  • Contact: Alexis Serra als9220@nyp.org

VENT-AVOID

  • ClinicalTrials.gov:​​​​​​​​​​​​​​ ​​​​​​​NCT03255057
  • Rationale: To evaluate the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
  • Inclusion Criteria: ≥ 40 years old, carries a diagnosis of COPD, admitted with acute hypercapnic respiratory failure, and at high risk for intubation, failed non-invasive ventilation, or inability to wean from the ventilator within 5 days of intubation.
  • Principal Investigator: Daniel Brodie, MD
  • Recruiting: Yes
  • Contact: Alexis Serra als9220@nyp.org