Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Albumin Infusion Effect in Hepatic Encephalopathy (BETA)
2.2. Patient Selection
2.3. Study Protocol
2.4. Outcome
2.5. Statistics
2.6. Metanalysis: Albumin Infusion Effect in Hepatic Encephalopathy (BETA) and Effects of Intravenous Albumin in Patients with Cirrhosis and Episodic Hepatic Encephalopathy (ALFAE)
2.7. Statistics
3. Results
3.1. Basal Clinical Characteristics
3.2. Complications during Follow-Up
3.3. Survival
3.4. Safety and Tolerability
3.5. Meta-Analysis Results: BETA and ALFAE Studies
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Placebo Group | Albumin Group | |
---|---|---|
n = 42 | n = 40 | |
Male, n (%) | 26(61.9) | 29(72.5) |
Age, median (IQR) | 69.1(63.3–75.3) | 66.5(59.9–73.6) |
BMI, median (IQR) | 24.5(23.2–26.5) | 24.2(23.2–26.8) |
Etiology, n (%) | ||
Alcohol related | 22(57.7) | 19(47.5) |
MAFLD | 2(4.9) | 4(10) |
Alcohol and HCV | 4(9.8) | 6(15) |
HCV | 5(12.2) | 6(15) |
Alcohol and MAFL | 2(4.9) | -- |
Other * | 7(8.8) | 5(6.1) |
Previous decompensations, n (%) | ||
Ascites | 35(83.3) | 30(75) |
Hepatic encephalopathy | 27(64.3) | 26(65) |
Spontaneous bacterial peritonitis | 7(16.7) | 7(17.5) |
Gastrointestinal bleeding | 11(26.2) | 11(27.6) |
Hepatorenal syndrome | 2(4.8) | 3(7.5) |
Hepatocellular carcinoma | 5(11.9) | 4(10) |
Other comorbidities, n (%) | ||
Hypertension | 26(66.7) | 23(59) |
Dyslipidemia | 9(23.1) | 7(17.9) |
Diabetes | 20(51.3) | 14(35.9) |
Severity score, median (IQR) | ||
MELD | 17(16–20) | 17(15–20) |
Treatment at inclusion, n (%) | ||
Rifaximin and/or lactulose | 35(83.3) | 31(77.5) |
Laboratory parameters, median (IQR) | ||
Hemoglobin g/dL | 10.6(9.9–13) | 10.9(9.3–11.8) |
Leukocytes x109/L | 5.06(3.8–7.4) | 5.09(4.06–6.6) |
Platelets x10E9/L | 82.5(64–109) | 76.5(57.5–106.5) |
Sodium mEq/L | 135.8(132.8–138.6) | 136.2(134–139) |
AST IU/L | 44(31–64) | 51(36–75) |
ALT IU/L | 26(18–35) | 32.5(22–43.5) |
Bilirubin mg/dL | 3.2(1.7–4.6) | 2.97(1.91–5) |
Albumin g/dL | 2.85(2.35–3.01) | 2.6(2.41–2.93) |
INR | 1.53(1.37–1.71) | 1.55(1.35–1.83) |
Creatinine (mg/dL) | 1.08(0.77–1.53) | 0.99(0.7–1.32) |
Mean Arterial Pressure (mmHg) | 82.6(76–94.3) | 78.7(72.5–89.3) |
Current liver-related decompensations, n (%) ♦ | ||
Ascites | 19(45.2) | 17(42.5) |
Hepatorenal syndrome | 1(2.4) | -- |
Precipitant factors, n (%) | ||
Infection | 11(26.1) | 12(30) |
Constipation | 9(21.4) | 9(22.5) |
Dehydration | 4(9.5) | 3(7.5) |
Diuretics | 14(33.3) | 23(59) ** |
West Haven at screening, n (%) | ||
II | 30(71.4) | 31(77.5) |
III | 11(26.2) | 9(22.5) |
IV | 1(2.4) | -- |
CHESS scale | 2.5 (1–6) | 2(1–4) |
Time Point | Placebo Number of Patients with MHE/Number of Total Evaluated Patients and Percentage | Albumin Number of Patients with MHE/Number of Total Evaluated Patients and Percentage |
---|---|---|
Day 2–3 | 6/9 (66.6) | 5/13(38.5) |
Day 7 | 7/12(58.3) | 4/17(23.5) |
Day 30 | 4/10(40) | 5/16(31.3) |
Day 60 | 1/4(25) | 5/14(35.7) |
Day 90 | 6/12(50) | 4/16(25) |
Day 180 | 2/6(33.3) | 3/13(7.7) |
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Ventura-Cots, M.; Simón-Talero, M.; Poca, M.; Ariza, X.; Masnou, H.; Sanchez, J.; Llop, E.; Cañete, N.; Martín-Llahí, M.; Amador, A.; et al. Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis. J. Clin. Med. 2021, 10, 4885. https://doi.org/10.3390/jcm10214885
Ventura-Cots M, Simón-Talero M, Poca M, Ariza X, Masnou H, Sanchez J, Llop E, Cañete N, Martín-Llahí M, Amador A, et al. Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis. Journal of Clinical Medicine. 2021; 10(21):4885. https://doi.org/10.3390/jcm10214885
Chicago/Turabian StyleVentura-Cots, Meritxell, Macarena Simón-Talero, Maria Poca, Xavier Ariza, Helena Masnou, Jordi Sanchez, Elba Llop, Núria Cañete, Marta Martín-Llahí, Alberto Amador, and et al. 2021. "Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis" Journal of Clinical Medicine 10, no. 21: 4885. https://doi.org/10.3390/jcm10214885
APA StyleVentura-Cots, M., Simón-Talero, M., Poca, M., Ariza, X., Masnou, H., Sanchez, J., Llop, E., Cañete, N., Martín-Llahí, M., Amador, A., Martínez, J., Clemente-Sanchez, A., Puente, A., Torrens, M., Alvarado-Tapias, E., Napoleone, L., Miquel-Planas, M., Ardèvol, A., Casas Rodrigo, M., ... Genescà, J. (2021). Effects of Albumin on Survival after a Hepatic Encephalopathy Episode: Randomized Double-Blind Trial and Meta-Analysis. Journal of Clinical Medicine, 10(21), 4885. https://doi.org/10.3390/jcm10214885