Browsing by Author "Douglas, Ivor S."

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    Assessment of Right Ventricular Function in the Research Setting: Knowledge Gaps and Pathways Forward. An Official American Thoracic Society Research Statement
    (American Thoracic Society, 2018-08-15) Lahm, Tim; Douglas, Ivor S.; Archer, Stephen L.; Bogaard, Harm J.; Chesler, Naomi C.; Haddad, Francois; Hemnes, Anna R.; Kawut, Steven M.; Kline, Jeffrey A.; Kolb, Todd M.; Mathai, Stephen C.; Mercier, Olaf; Michelakis, Evangelos D.; Naeije, Robert; Tuder, Rubin M.; Ventetuolo, Corey E.; Vieillard-Baron, Antoine; Voelkel, Norbert F.; Vonk-Noordegraaf, Anton; Medicine, School of Medicine
    BACKGROUND: Right ventricular (RV) adaptation to acute and chronic pulmonary hypertensive syndromes is a significant determinant of short- and long-term outcomes. Although remarkable progress has been made in the understanding of RV function and failure since the meeting of the NIH Working Group on Cellular and Molecular Mechanisms of Right Heart Failure in 2005, significant gaps remain at many levels in the understanding of cellular and molecular mechanisms of RV responses to pressure and volume overload, in the validation of diagnostic modalities, and in the development of evidence-based therapies. METHODS: A multidisciplinary working group of 20 international experts from the American Thoracic Society Assemblies on Pulmonary Circulation and Critical Care, as well as external content experts, reviewed the literature, identified important knowledge gaps, and provided recommendations. RESULTS: This document reviews the knowledge in the field of RV failure, identifies and prioritizes the most pertinent research gaps, and provides a prioritized pathway for addressing these preclinical and clinical questions. The group identified knowledge gaps and research opportunities in three major topic areas: 1) optimizing the methodology to assess RV function in acute and chronic conditions in preclinical models, human studies, and clinical trials; 2) analyzing advanced RV hemodynamic parameters at rest and in response to exercise; and 3) deciphering the underlying molecular and pathogenic mechanisms of RV function and failure in diverse pulmonary hypertension syndromes. CONCLUSIONS: This statement provides a roadmap to further advance the state of knowledge, with the ultimate goal of developing RV-targeted therapies for patients with RV failure of any etiology.
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    Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial
    (Elsevier, 2020) Douglas, Ivor S.; Alapat, Philip M.; Corl, Keith A.; Exline, Matthew C.; Forni, Lui G.; Holder, Andre L.; Kaufman, David A.; Khan, Akram; Levy, Mitchell M.; Martin, Gregory S.; Sahatjian, Jennifer A.; Seeley, Eric; Self, Wesley H.; Weingarten, Jeremy A.; Williams, Mark; Hansell, Douglas M.; Medicine, School of Medicine
    Background: Fluid and vasopressor management in septic shock remains controversial. In this randomized controlled trial, we evaluated the efficacy of dynamic measures (stroke volume change during passive leg raise) to guide resuscitation and improve patient outcome. Research question: Will resuscitation that is guided by dynamic assessments of fluid responsiveness in patients with septic shock improve patient outcomes? Study design and methods: We conducted a prospective, multicenter, randomized clinical trial at 13 hospitals in the United States and United Kingdom. Patients presented to EDs with sepsis that was associated hypotension and anticipated ICU admission. Intervention arm patients were assessed for fluid responsiveness before clinically driven fluid bolus or increase in vasopressors occurred. The protocol included reassessment and therapy as indicated by the passive leg raise result. The control arm received usual care. The primary clinical outcome was positive fluid balance at 72 hours or ICU discharge, whichever occurred first. Results: In modified intent-to-treat analysis that included 83 intervention and 41 usual care eligible patients, fluid balance at 72 hours or ICU discharge was significantly lower (-1.37 L favoring the intervention arm; 0.65 ± 2.85 L intervention arm vs 2.02 ± 3.44 L usual care arm; P = .021. Fewer patients required renal replacement therapy (5.1% vs 17.5%; P = .04) or mechanical ventilation (17.7% vs 34.1%; P = .04) in the intervention arm compared with usual care. In the all-randomized intent-to-treat population (102 intervention, 48 usual care), there were no significant differences in safety signals. Interpretation: Physiologically informed fluid and vasopressor resuscitation with the use of the passive leg raise-induced stroke volume change to guide management of septic shock is safe and demonstrated lower net fluid balance and reductions in the risk of renal and respiratory failure. Dynamic assessments to guide fluid administration may improve outcomes for patients with septic shock compared with usual care.
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    Post-Intensive Care Syndrome and Caregiver Burden: A Post Hoc Analysis of a Randomized Clinical Trial
    (American Medical Association, 2025-04-01) Ahn, Soojung; LaNoue, Marianna; Su, Han; Moale, Amanda C.; Scheunemann, Leslie P.; Kiehl, Amy L.; Douglas, Ivor S.; Exline, Matthew C.; Gong, Michelle N.; Khan, Babar A.; Owens, Robert L.; Pisani, Margaret A.; Rock, Peter; Jackson, James C.; Ely, E. Wesley; Girard, Timothy D.; Boehm, Leanne M.; Medicine, School of Medicine
    Importance: Understanding the reciprocal association between post-intensive care syndrome (PICS) and caregiver burden is crucial for optimal care of patients and caregivers following critical illness. Objective: To evaluate the associations between patient post-intensive care impairments and caregiver burden. Design, setting, and participants: This secondary analysis of the MIND-USA study, a multicenter randomized clinical trial, which enrolled patients admitted to intensive care units (ICU) from 16 academic medical centers across the US (December 2011 to August 2017), included 148 patient-caregiver dyads. Patients were adults aged 18 years or older with ICU delirium randomized to receive haloperidol, ziprasidone, or placebo. A caregiver who provided unpaid assistance to the patient was identified at enrollment. PICS and caregiver burden were assessed at 3 months and 12 months after randomization. Statistical analysis was performed from March 2023 to April 2024. Main outcomes and measures: ICU survivors were assessed for PICS domains, including physical and cognitive function, and posttraumatic stress disorder using the Katz Activities of Daily Living, the Functional Activities Questionnaire, the Telephone Interview for Cognitive Status, and the Posttraumatic Stress Disorder Checklist-Civilian version, respectively. Caregiver burden was assessed using the Zarit Burden Interview. The associations between patient PICS and caregiver burden at 3 and 12 months were examined using structural equation modeling. Results: Of 148 patients included in this study with a median (IQR) age of 58 (48-65) years, the majority identified as male (79 patients [53.4%]), and there were 16 (10.8%) Black, 139 (93.9%) non-Hispanic, and 127 (85.8%) White patients. PICS and caregiver burden at 3-month follow-up was positively associated with these outcomes at 12-month follow-up (PICS: β = 0.69; 95% CI, 0.50 to 0.88; P < .001; caregiver burden: β = 0.68; 95% CI, 0.53 to 0.82; P < .001). However, contrary to the study hypotheses, significant associations between 3-month PICS and 12-month caregiver burden and between 3-month caregiver burden and 12-month PICS were not observed (PICS→caregiver burden: β = 0.82; 95% CI, -0.02 to 1.66; P = .09; caregiver burden→PICS: β = 0.00; 95% CI, -0.03 to 0.03; P = .95). There was significant covariance between PICS and caregiver burden at each time point. Conclusions and relevance: In this secondary analysis of a randomized clinical trial of ICU survivors and their caregivers, patient PICS and caregiver burden were associated at concurrent time points but were not associated with each other longitudinally.