A randomised controlled trial of Heparin versus EthAnol Lock THerapY for the prevention of Catheter Associated infecTion in Haemodialysis patients – the HEALTHY-CATH trial

Table 2 Outcomes of the trial for ethanol lock and heparin lock arms are shown

Variable	Ethanol lock	Heparin lock	IRR (95% CI ); p value
Variable	(/1000 catheter days; 95%CI)	(/1000 catheter days; 95%CI)	IRR (95% CI ); p value
Total observation period from trial entry (days)	3614	1834
Total Complications (intention to treat): infective and non-infective	9 (2.5; 95%	8 (4.4; 95%	0.57 (0.22-1.5);
	CI 1.1-4.7)	CI 1.9-8.6)	p = 0.25
*Non-infective*	7 (1.9; 95%	4 (2.2; 95%	0.88 (0.26- 3.0);
*Non-infective*	CI 0.78-4.0)	CI 0.59-5.6)	p=0.85
-→Flow difficulties	5 (1.4; 95%	3 (1.6; 95%	0.85 (0.20-3.5);
-→Flow difficulties	CI 0.45-3.2)	CI 0.32-4.8)	p=0.82
-→Thrombosis	0	0
-→Mechanical dysfunction	2	1
*Infective*	2* (0.55; 95%	4 (2.2; 95%	0.25 (0.05-1.4);
*Infective*	CI 0.067-2.0)	CI 0.59-5.6)	p=0.113
-→CA-BSI - definite or probable^¥	1 (0.28; 95%	3 (0.85; 95%	0.17 (0.02-1.63);
-→CA-BSI - definite or probable^¥	CI.00-1.5)	CI 0.20-3.5)	p=0.12
-→CA-BSI suspected	0	1
-→Exit site infection	1	0
-→Tunnel infection	0	0

* This number represents all infectious complications on an intention-to-treat basis. One CA-BSI occurred in a catheter after exit from the trial in the ethanol arm. Therefore, in Table 4, the infectious complications resulting in trial exit are listed as 1 because the second infection occurred after trial exit.