Trial reportAmerican journal of respiratory and critical care medicine2026
Effects of an early restrictive versus liberal fluid strategy on long-term patient-centered outcomes in sepsis-induced hypotension: an open-label, randomized controlled trial.
Trial report in American journal of respiratory and critical care medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03434028 (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis), which is not on this map. Cited by 1 paper.
0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Anselm JordaDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-5500-5878
Georg GelbeneggerDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.ORCID 0000-0003-0995-7178
Nathan I ShapiroDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.
Ivor S DouglasDepartment of Medicine, New York Medical College, Westchester Medical Center, Valhalla, NY, United States.ORCID 0000-0002-4541-1431
Casey WhitmanPalliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
Zhe ChenDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
Joseph A HippensteelDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, United States.ORCID 0000-0003-4082-6993
Lee A KamphuisVA Center for Clinical Management Research, Ann Arbor, VA, Ann Arbor, MI, United States.
Robert J FlickPulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.ORCID 0000-0002-8155-6398
Michael O HarhayPalliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.ORCID 0000-0002-0553-674X
Ellen CaldwellDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Washington, Seattle, WA, United States.ORCID 0000-0001-6034-9480
Markus ZeitlingerDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.ORCID 0000-0002-1873-3953
Bernd JilmaDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.ORCID 0000-0001-5652-7977
Theodore J IwashynaPulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University, Baltimore, MD, United States.ORCID 0000-0002-4226-9310
Catherine L HoughDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland, OR, United States.
Catherine L AuriemmaPalliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.ORCID 0000-0003-4803-0375
Funding
CCC for NHLBI Prevention and Early Treatment of Acute Lung Injury PETAL NetworkU01HL123009 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI FOULKES, ANDREA S, THOMPSON, BOYD TAYLOR · 2014 to 2021
$67.2M
Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute LungU01HL123022 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SHAPIRO, NATHAN I, TALMOR, DANIEL STUART · 2014 to 2020
$2.9M
Advancing the design, analysis, and interpretation of acute respiratory distress syndrome trials using modern statistical toolsR01HL168202 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI Michael Oscar Harhay, Fan Li · 2023 to 2026
$2.9M
Prevention and Early Treatment of Acute Lung InjuryU01HL123004 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MATTHAY, MICHAEL A. · 2014 to 2020
$2.6M
Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute LungU01HL123031 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HYZY, ROBERT C, PARK, PAULINE K · 2014 to 2020
$2.6M
Enhancing the Surrogate Informed Consent Process for Critical Care ResearchU01HL123010 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI GINDE, ADIT A., MOSS, MARC · 2014 to 2020
$2.6M
Prevention and Early Treatment of Acute Lung Injury Clinical Trials NetworkU01HL123033 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI RICE, TODD W · 2014 to 2020
$2.4M
Preventive and Early Treatment of Acute Lung Injury Clinical Trials Network- Pgh - SupplementU01HL123020 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ANGUS, DEREK C, YEALY, DONALD M · 2014 to 2020
$2.4M
Long Term Outcomes and Macrophage Biology in Patients with EVALIU01HL123018 · NHLBI · IHC HEALTH SERVICES, INC. · PI BLEDSOE, JOSEPH R, BROWN, SAMUEL MORRIS · 2014 to 2020
$2.4M
Pacific Northwest Clinical Center for the NHLBI PETAL NetworkU01HL123008 · NHLBI · UNIVERSITY OF WASHINGTON · PI HOUGH, CATHERINE LEE, ROBINSON, BRYCE · 2014 to 2020
$2.3M
Acute Lung Injury Group New England Program to Support PETAL Network ResearchU01HL122989 · NHLBI · BAYSTATE MEDICAL CENTER, INC. · PI STEINGRUB, JAY S · 2014 to 2020
$2.2M
Einstein PETAL: Clinical Center for the PETAL NetworkU01HL122998 · NHLBI · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI GONG, MICHELLE NG, RICHARDSON, LYNNE D. · 2014 to 2020
rationaleThe impact of fluid resuscitation strategies on patient-centered outcomes of sepsis survivors is unknown.
objectivesTo assess the effect of an early restrictive or liberal fluid resuscitation strategy on long-term functional outcomes in patients with sepsis-induced hypotension.
methodsSHAMROC (Sepsis-induced Hypotension: Assessing effect of Method of Resuscitation On Patient-centered Outcomes) prospectively assessed the impact of random assignment to a restrictive or liberal fluid resuscitation strategy for sepsis-induced hypotension outcomes at 6 and 12 months after randomization in the NIH NHLBI PETAL Network's CLOVERS trial (NCT03434028). The pre-specified analyses used trimmed means at 50% to prevent informative censoring of deceased patients. MEASUREMENTS AND MAIN
resultsOf the 1563 participants included in the CLOVERS trial, 898 (57%) were included in the SHAMROC trial. As 196 were lost to follow-up, 702 participants were analyzed at 6 months (431 survivors and 271 non-survivors). Baseline characteristics were similar between the groups. At 6 months, no group differences were observed in cognitive function (restrictive versus liberal; trimmed mean difference in Montreal Cognitive Assessment-Blind Score, 0.11, 95% CI -1.44-1.70), executive function (trimmed mean difference in Hayling Sentence Completion Test, 0.38, 95% CI -0.97-1.76), disability status (trimmed mean difference in Activity of Daily Living Score, 0.03, 95% CI -0.84-0.90), mobility (trimmed mean difference in PROMIS Mobility Score, 0.72, 95% CI -2.20-3.64), and health-related quality of life (trimmed mean difference in EQ-5D-5L, -0.01, 95% CI -0.07-0.06). Outcomes also did not differ at 12 months.
conclusionsIn this long-term follow-up of a randomized controlled trial of patients with sepsis-induced hypotension, the restrictive fluid strategy used in this study resulted in similar cognitive and physical function at 6 and 12 months, compared to a liberal fluid strategy.
Indexed as
Fluid TherapyHypotensionResuscitationSepsisAgedFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeTreatment Outcomebacteremiacritically illfluid resuscitationintensive care unit (ICU)septic
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.
Effects of an early restrictive versus liberal fluid strategy on long-term patient-centered outcomes in sepsis-induced hypotension: an open-label, randomized controlled trial. · full record | OpenQuestion