Keratinocyte growth factor for the treatment of the acute respiratory distress syndrome (KARE): a randomised, double-blind, placebo-controlled phase 2 trial

The Lancet. Respiratory Medicine
Daniel F McAuleyCecilia M O'Kane

Abstract

Data from in-vitro, animal, and human lung injury models suggest that keratinocyte growth factor (KGF) might be beneficial in acute respiratory distress syndrome (ARDS). The objective of this trial was to investigate the effect of KGF in patients with ARDS. We did a double-blind, allocation concealed, randomised, placebo-controlled phase 2 trial in two intensive care units in the UK, involving patients fulfilling the American-European Consensus Conference Definition of ARDS. Patients were randomly assigned (1:1) by computer-generated randomisation schedule with variable block size stratified by site and presence of severe sepsis requiring vasopressors to receive either recombinant human KGF (palifermin 60 μg/kg) or placebo (0·9% sodium chloride solution) daily for a maximum of 6 days. Both patients and investigators were masked to treatment. The primary endpoint was oxygenation index (OI) at day 7. Analyses were by intention to treat. The trial is registered with International Standard Randomised Controlled Trial Registry, number ISRCTN95690673. Between Feb 23, 2011, and Feb 26, 2014, 368 patients were assessed for eligibility for inclusion in the trial. Of the 60 patients recruited, 29 patients were randomly assigned to receiv...Continue Reading

Citations

Dec 12, 2017·International Anesthesiology Clinics·Paola Aranda-Valderrama, Ata Murat Kaynar
Feb 28, 2018·Clinical Pharmacology and Therapeutics·Musaddique HussainXimei Wu
Dec 1, 2018·Anesthesiology·Tài PhamUNKNOWN LUNG SAFE Investigators* and the European Society of Intensive Care Medicine Trials Group
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