A nebulised antitumour necrosis factor receptor-1 domain antibody in patients at risk of postoperative lung injury: A randomised, placebo-controlled pilot study
BACKGROUND
Tumour necrosis factor receptor 1 (TNFR1) signalling mediates the cell death and inflammatory effects of TNF-α.
OBJECTIVE
The current clinical trial investigated the effects of a nebulised TNFR1 antagonist (GSK2862277) on signs of lung injury in patients undergoing oesophagectomy.
DESIGN
Randomised double-blind (sponsor unblind), placebo-controlled, parallel group study.
SETTING
Eight secondary care centres, the United Kingdom between April 2015 and June 2017.
PATIENTS
Thirty-three patients undergoing elective transthoracic oesophagectomy.
INTERVENTIONS
Patients randomly received a single nebulised dose (26 mg) of GSK2862277 (n = 17) or placebo (n = 16), given 1 to 5 h before surgery; 14 and 16, respectively competed the study.
MAIN OUTCOME MEASUREMENTS
Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints were measured. The primary endpoint was the change from baseline in pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution. Adjusted point estimates and 95% credible intervals (analogous to conventional confidence intervals) were constructed for each treatment using Bayesian statistical models.
RESULTS
The mean change (with 95% credible intervals) from baseline in PVPI on completion of surgery was 0.00 (−0.23, 0.39) in the placebo and 0.00 (−0.24, 0.37) in the GSK2862277 treatment groups. There were no signific...
Source: European Journal of Anaesthesiology - Category: Anesthesiology Tags: Ventilation Source Type: research