Trial reportCritical care medicine2012
A randomized trial of recombinant human granulocyte-macrophage colony stimulating factor for patients with acute lung injury.
Trial report in Critical care medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 106 papers, 5 of them syntheses that pooled 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.
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.
A Randomized Trial of GM-CSF in Patients With ALI/ARDS
A Phase I Study of Inhaled GM-CSF in the Treatment of Respiratory Virus-associated Severe Pneumonia
Using GM-CSF as a Host Directed Therapeutic Against COVID-19 - a Phase 2 Investigator Initiated Trial
Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER
Who cites it
106 citing papers in PubMed, 5 syntheses or guidelines pooled it, 151 citations in OpenAlex.
- Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review.Critical care (London, England) · 2023Pooled it
- A systematic review and meta-analysis of enrollment into ARDS and sepsis trials published between 2009 and 2019 in major journals.Critical care (London, England) · 2021Pooled it
- Impact of differences in acute respiratory distress syndrome randomised controlled trial inclusion and exclusion criteria: systematic review and meta-analysis.British journal of anaesthesia · 2021Pooled it
- Between-trial heterogeneity in ARDS research.Intensive care medicine · 2021Pooled it
- Pharmacological agents for adults with acute respiratory distress syndrome.The Cochrane database of systematic reviews · 2019Pooled it
- A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.Annals of the American Thoracic Society · 2020Trial
- Randomised controlled trial of GM-CSF in critically ill patients with impaired neutrophil phagocytosis.Thorax · 2018Trial
- Psychiatric Symptoms in Survivors of Acute Respiratory Distress Syndrome. Effects of Age, Sex, and Immune Modulation.Annals of the American Thoracic Society · 2017Trial
- A novel treatment of cystic fibrosis acting on-target: cysteamine plus epigallocatechin gallate for the autophagy-dependent rescue of class II-mutated CFTR.Cell death and differentiation · 2016Trial
- Enrichment of the lung microbiome with gut bacteria in sepsis and the acute respiratory distress syndrome.Nature microbiology · 2016Trial
- Efficacy and Safety of Glutamine-supplemented Parenteral Nutrition in Surgical ICU Patients: An American Multicenter Randomized Controlled Trial.Annals of surgery · 2016Trial
- Trial
- Plasma angiopoietin 2 concentrations are related to impaired lung function and organ failure in a clinical cohort receiving high-dose interleukin 2 therapy.Shock (Augusta, Ga.) · 2014Trial
- Keratinocyte growth factor promotes epithelial survival and resolution in a human model of lung injury.American journal of respiratory and critical care medicine · 2014Trial
- Restoration of CFTR function in patients with cystic fibrosis carrying the F508del-CFTR mutation.Autophagy · 2014Trial
- Immunophenotyping and protein profiling of Fontan-associated plastic bronchitis airway casts.Annals of the American Thoracic Society · 2013Trial
- A randomised trial of granulocyte-macrophage colony-stimulating factor for neonatal sepsis: outcomes at 2 years.Archives of disease in childhood. Fetal and neonatal edition · 2013Trial
- Immunology of Sepsis.Clinics in chest medicine · 2026Review
- Mechanisms associated with progression from lobar inflammation to bilateral lung injury: an experimental study.Respiratory research · 2026Article
- One syndrome, many diseases: toward precision pharmacotherapy in acute respiratory distress syndrome.Frontiers in pharmacology · 2026Review
46 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
rationaleDespite recent advances in critical care and ventilator management, acute lung injury and acute respiratory distress syndrome continue to cause significant morbidity and mortality. Granulocyte-macrophage colony stimulating factor may be beneficial for patients with acute respiratory distress syndrome.
objectivesTo determine whether intravenous infusion of granulocyte-macrophage colony stimulating factor would improve clinical outcomes for patients with acute lung injury/acute respiratory distress syndrome.
designA randomized, double-blind, placebo-controlled clinical trial of human recombinant granulocyte-macrophage colony stimulating factor vs. placebo. The primary outcome was days alive and breathing without mechanical ventilatory support within the first 28 days after randomization. Secondary outcomes included mortality and organ failure-free days.
settingMedical and surgical intensive care units at three academic medical centers. PATIENTS: One hundred thirty individuals with acute lung injury of at least 3 days duration were enrolled, out of a planned cohort of 200 subjects.
interventionsPatients were randomized to receive human recombinant granulocyte-macrophage colony stimulating factor (64 subjects, 250 μg/M) or placebo (66 subjects) by intravenous infusion daily for 14 days. Patients received mechanical ventilation using a lung-protective protocol. MEASUREMENTS AND MAIN
resultsThere was no difference in ventilator-free days between groups (10.7 ± 10.3 days placebo vs. 10.8 ± 10.5 days granulocyte-macrophage colony stimulating factor, p = .82). Differences in 28-day mortality (23% in placebo vs. 17% in patients receiving granulocyte-macrophage colony stimulating factor (p = .31) and organ failure-free days (12.8 ± 11.3 days placebo vs. 15.7 ± 11.9 days granulocyte-macrophage colony stimulating factor, p = .16) were not statistically significant. There were similar numbers of serious adverse events in each group.
conclusionsIn a randomized phase II trial, granulocyte-macrophage colony stimulating factor treatment did not increase the number of ventilator-free days in patients with acute lung injury/acute respiratory distress syndrome. A larger trial would be required to determine whether treatment with granulocyte-macrophage colony stimulating factor might alter important clinical outcomes, such as mortality or multiorgan failure. (ClinicalTrials.gov number, NCT00201409 [ClinicalTrials.gov]).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.