Point-of-care continuous 13C-methacetin breath test improves decision making in acute liver disease: Results of a pilot clinical trial

Table 1 Definition of normality for breath test parameters and blood tests

	Units	Normal values	± 30% of normal
Breath test	%/h	> 30	> 21
AL	U/L	< 53	< 69
AST	U/L	< 60	< 78
INR	U/L	1.00	< 1.30
BIL	&mgr;mol/L	< 17	< 22

Table 2 Liver disease etiology and outcome

Etiology	Number of patients	Number recovered	Number deceased
Autoimmune hepatitis	5	4	1
Drug induced liver injury	3	3	0
Acute HBV	2	2	0
Acute HAV	2	2	0
Wilson’s disease	1	1	0
Pregnancy associated	1	1	0
Space occupying lesion	1	0	1

Table 3 Liver tests parameters (mean ± SD)

Parameter	Female	Male	Overall
No. of patients	8	7	15
Weight (kg)	70.13 ± 20.03 (52-115)	82 ± 19.59 (55-115)	75.67 ± 20.07 (52-115)
Height (cm)	163.75 ± 6.69 (155-176)	175.57 ± 5.32 (167-184)	169.27 ± 8.47 (155-184)
BMI (kg/m2)	25.91 ± 5.69 (19.95-37.13)	26.53 ± 5.86 (18.59-35.89)	26.20 ± 5.57 (18.59-37.13)
Age (yr)	33.50 ± 17.04 (18-61)	31.14 ± 14.02 (14-53)	32.40 ± 15.19 (14-61)
ALT (IU)	1162.38 ± 1926.69 (45-5795)	2807.86 ± 2468.82 (58-7535)	1930.27 ± 2278.22 (45-7535)
AST (IU)	996.88 ± 1306.56 (50-3928)	1475.71 ± 1104.09 (96-3294)	1220.33 ± 1198.8 (50-3928)
Bilirubin (&mgr;mol/L)	193.50 ± 207.39 (9-565)	232.86 ± 194.49 (41-599)	211.87 ± 195.27 (9-599)
INR (SI)	2.09 ± 0.90 (1.00-4.06)	1.80 ± 0.62 (1.26-3.02)	1.95 ± 0.77 (1.00-4.06)

Table 4 Correlation coefficients for blood test versus breath test parameters

	PDR peak	Peak time	PDR10	PDR15	PDR20	PDR30	PDR60	CPDR10	CPDR15	CPDR20	CPDR30	CPDR60
BIL	-0.556	0.394	-0.519	-0.544	-0.575	-0.588	-0.519	-0.456	-0.513	-0.540	-0.580	-0.595
ALT	-0.276	0.235	-0.258	-0.279	-0.293	-0.318	-0.403	-0.248	-0.266	-0.276	-0.306	-0.326
AST	-0.338	0.226	-0.306	-0.337	-0.358	-0.384	-0.451	-0.279	-0.311	-0.329	-0.362	-0.405
AP	-0.239	0.219	-0.308	-0.280	-0.268	-0.172	-0.110	-0.283	-0.301	-0.296	-0.282	-0.198
GGT	0.504	-0.344	0.510	0.538	0.507	0.418	0.203	0.340	0.449	0.483	0.497	0.438
LDH	-0.313	0.221	-0.313	-0.329	-0.329	-0.325	-0.314	-0.264	-0.302	-0.317	-0.333	-0.332
INR	-0.436	0.441	-0.412	-0.435	-0.452	-0.431	-0.386	-0.390	-0.420	-0.437	-0.458	-0.562
PTT	-0.565	0.239	-0.413	-0.509	-0.579	-0.632	-0.471	-0.360	-0.420	-0.471	-0.543	-0.598
PT%	0.628	-0.364	0.475	0.573	0.635	0.673	0.513	0.440	0.489	0.540	0.609	0.660
F-VII%	0.648	-0.828	0.720	0.737	0.723	0.613	0.581	0.661	0.694	0.715	0.725	0.688
F-V%	0.576	-0.495	0.598	0.521	0.546	0.579	0.503	0.527	0.548	0.554	0.582	0.591

Results obtained from the device were expressed as percentage of administered dose of ¹³C recovery (PDR) and the cumulative percentage of ¹³C recovery over time (CPDR) at 10, 15, 20, 30 and 60 min after ingestion of methacetin, as well as the PDR peak, and peak time. PDR refers to the rate at which the ¹³C substrate is metabolized and exhaled expressed as percent per hour. PDR is based on the change in ¹³C/¹²C ratio for each patient. CPDR is the numeric integral of PDR, and describes the total percent of substrate metabolized at any given accumulated time. Data are expressed in units of percent. ALT: Alanine aminotransferase; AST: Aspartate amino transferase; GGT: Gamma glutamyl transpepetidase; AP: Alkaline phosphatase; F-V, F-VII: Factor 5 and 7; PDR: Percent dose recovery at different time points in minutes; CPDR: Cumulative percent dose recovery at different time points.

Table 5 Blood tests versus breath test parameters (mean, SD)

	Point of stable improvement (days after treatment)	Convergence to normality (days after treatment)
Breath test	2.85, 2.23	8.89, 11.5
ALT	7.33, 11.06	28.24, 21.69
AST	7.62, 11.44	12.96, 6.96
INR	8.62, 12.1	16.02, 24.71
BIL	7, 10.61	23.63, 22.61