Colchicine in post-operative Fontan patients

Abstract

Background: Prolonged effusions post-Fontan procedure are associated with morbidity. Fontan patients have higher pro-inflammatory cytokines in chest tube drainage compared to controls. Colchicine, an anti-inflammatory medication, decreases effusions in adults after cardiac surgery. We hypothesised that patients post-Fontan treated with colchicine would have decreased pro-inflammatory cytokine levels and shorter duration of chest tube drainage.

Methods: This pilot clinical trial enrolled nine patients (intention to treat); five completed the protocol (per protocol). Post-operative Fontan patients 20 months to 5 years receiving colchicine were compared to a previously published control cohort (n = 25). Per protocol patients received 0.6 mg colchicine daily starting post-operative day 2, ending 1 day after chest tube removal. Chest tube samples were taken on days 1-4, 7 and 10, or until removal and analysed with a 17-cytokine Bio-Plex Assay. Descriptive statistics and basic univariate comparisons were made.

Results: There was no difference in duration of chest tube drainage or length of stay between intention to treat patients and controls. Per protocol patients had shorter duration of chest tube drainage compared to controls (6 days [interquartile range 4.7-7], versus 10 days [7-11], p = 0.007) and shorter length of stay (7 days [5.5-9] versus 9 days [9-13], p = 0.005). Pro-inflammatory cytokines trended lower in per protocol patients.

Conclusions: In this pilot cohort, patients who completed the colchicine protocol post-Fontan procedure had shortened duration of chest tube drainage and length of stay. A decrease of pro-inflammatory cytokines may contribute to the mechanism of this change.ClinicalTrials.gov: Colchicine in Postoperative Fontan Patients (CPFP); NCT03575572; https://clinicaltrials.gov/ct2/show/NCT03575572.

Keywords: Chest tube drainage; Colchicine; Effusion; Fontan; Inflammation; Single ventricle.