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The objective of this randomized control clinical trial is to learn the role of albumin in patients with acute variceal bleed. The trial will include all adult patients with acute variceal bleeding and cirrhosis presenting to Medical Gastroenterology department at KGMU, Lucknow, U.P. India, will include patients with age between 18-70 years and all gender.
The primary endpoint will be re-bleeding during hospitalization and at 6 weeks. Participants will be randomized in two groups, the intervention group will receive albumin for 3 days along with standard treatment and comparison group will receive on standard treatment.
Albumin in acute variceal bleeding: A randomized controlled trial: ALB-AVB Trial
Introduction:
Albumin has been found to reduce mortality in patients with acute variceal bleeding in retrospective trials. However, there is no prospective data on this issue. We aim to conduct a randomized controlled trial on the role of albumin in patients with acute variceal bleeding.
Review of the literature Acute variceal bleeding is an important decompensating event in patients with cirrhosis. It is associated with 20-30% mortality in six weeks. Standard therapy with splanchnic vasoconstrictors and endoscopic band ligation is the mainstay of treatment. Previous studies have shown that albumin may decrease the mortality and re-bleeding rate in patients with AVB, however, there is no prospective data on this.
Apart from its oncotic properties albumin has different pleiotropic effects in patients with cirrhosis. It is an anti-oxidant and also binds to cytokines. Its anti-inflammatory property is responsible for reducing portal pressure and the risk of rebleeding. Currently, albumin is used in patients with acute kidney injury, spontaneous bacterial peritonitis and during large-volume paracentesis. There is also a theoretical risk of an increase in portal pressure in patients receiving albumin. The role of albumin in AVB is largely unknown. The current recommendation does not support its use in AVB however there is no strong evidence against it too. Currently, albumin has been shown to decrease mortality and decompensation in patients with cirrhosis. Large retrospective data from China have shown that albumin infusion is associated with reduced risk of rebleeding and mortality. In that study IV albumin of 40 grams/ day was associated with reduced mortality in patients with CTP-C cirrhosis. A perfectly designed RCT is warranted to explore the role of albumin in ABV.
Aim of the study:
To explore the role of albumin in patients with AVB. Study Methodology: It will be a randomised controlled trial conducted in the department of gastroenterology, KGMU Study Centre: Department of Gastroenterology, King George Medical University Lucknow Duration of the study: 6 months after the ethical approval
Sample Size Calculation:
Primary Outcome:
The primary endpoint is re-bleeding during hospitalization and at 6 weeks.
Standard Statistical Assumptions:
Expected re-bleeding rate in the control group (no albumin): 30% Expected reduction with intervention (albumin): 15% Significance level (α): 0.05 Power (1-β): 0.8
Formula for Binary Outcomes (Re-bleeding or No Re-bleeding):
n=(〖〖(Z〗_(∝/2)+Z_β)〗^2×[p_1 (1-p_1 )+p_2 (1-p_2 )])/(p_1-p_2 )^2
Where:
p1=0.30 (control event rate) p2=0.15 (intervention event rate) Zα/2=1.96 (for 95% confidence) Zβ=0.84 (for 80% power) Adding an attrition of minimum to 5% (0.05), the sample size for study obtained was that of 126 patients that is 63 patients in each arm. But for feasibility purposes it was rounded off to achieve a final sample size of 60 patients randomly allocated in each arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | All the participants with acute variceal bleed will be given albumin along with standard treatment |
|
| Comparator | No Intervention | This comparator group will not receive the drug. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin | Drug | All the participants with acute variceal bleed will be given albumin along with standard treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-bleeding rate | All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy. The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Re-bleeding rate in hospital and at six weeks will be measured. Time phrame is six weeks from the event. | Six weeks (Baveno VII Consensus) |
| In hospital mortality | All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy. The intervention planned is administration of Albumin 40 mg per day and in comparison group only standard treatment will be given In hospital mortality in both groups will be measured Time frame is six weeks | From enrollment to death or discharge, other outcome is measured in six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy. The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Mortality rate at 42 days will be measured | From enrollment to 42 days (Baveno VII Consensus) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Sumit Rungta, DM- Medical Gastroenterology | Contact | +919935537944 | drsumitrungta79@gmail.com | |
| Dr Sayan Malakar, DM- Medical Gastroenterology | Contact | +919007057890 | oneandonludrsayan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Sumit Rungta | Lucknow | Uttar Pradesh | 206003 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35120736 | Result | de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30. | |
| 32576140 | Result | Wang Z, Xie YW, Lu Q, Yan HL, Liu XB, Long Y, Zhang X, Yang JL. The impact of albumin infusion on the risk of rebleeding and in-hospital mortality in cirrhotic patients admitted for acute gastrointestinal bleeding: a retrospective study of a single institute. BMC Gastroenterol. 2020 Jun 23;20(1):198. doi: 10.1186/s12876-020-01337-5. |
| Label | URL |
|---|---|
| https://clinicaltrials.gov/study/NCT03451292 | View source |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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Parallel group randomized controlled trial
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| Need for rescue therapy | All patients will receive vasoconstrictors after the initial hemodynamic resuscitation. Patients will receive terlipressin/ octreotide along with standard medical and endoscopic therapy. The intervention planned is administration of Albumin 40 mg/day and in comparison group only standard treatment will be given Need for rescue therapy rate will be measured during hospitalization | From hospitalization to need for rescue therapy within 42 days of enrollment (Baveno VII Consensus) |
| 21484145 | Result | Sarin SK, Kumar A, Angus PW, Baijal SS, Baik SK, Bayraktar Y, Chawla YK, Choudhuri G, Chung JW, de Franchis R, de Silva HJ, Garg H, Garg PK, Helmy A, Hou MC, Jafri W, Jia JD, Lau GK, Li CZ, Lui HF, Maruyama H, Pandey CM, Puri AS, Rerknimitr R, Sahni P, Saraya A, Sharma BC, Sharma P, Shiha G, Sollano JD, Wu J, Xu RY, Yachha SK, Zhang C; Asian Pacific Association for the Study of the Liver (APASL) Working Party on Portal Hypertension. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int. 2011 Jun;5(2):607-24. doi: 10.1007/s12072-010-9236-9. Epub 2011 Feb 19. |
| 22732511 | Result | Guevara M, Terra C, Nazar A, Sola E, Fernandez J, Pavesi M, Arroyo V, Gines P. Albumin for bacterial infections other than spontaneous bacterial peritonitis in cirrhosis. A randomized, controlled study. J Hepatol. 2012 Oct;57(4):759-65. doi: 10.1016/j.jhep.2012.06.013. Epub 2012 Jun 23. |
| 23934414 | Result | Cheng HC, Chang WL, Chen WY, Tsai YC, Yeh YC, Sheu BS. Intravenous albumin shortens the duration of hospitalization for patients with hypoalbuminemia and bleeding peptic ulcers: a pilot study. Dig Dis Sci. 2013 Nov;58(11):3232-41. doi: 10.1007/s10620-013-2821-8. Epub 2013 Aug 11. |
| 26831575 | Result | Artigas A, Wernerman J, Arroyo V, Vincent JL, Levy M. Role of albumin in diseases associated with severe systemic inflammation: Pathophysiologic and clinical evidence in sepsis and in decompensated cirrhosis. J Crit Care. 2016 Jun;33:62-70. doi: 10.1016/j.jcrc.2015.12.019. Epub 2015 Dec 29. |
| 30905652 | Result | Fernandez J, Claria J, Amoros A, Aguilar F, Castro M, Casulleras M, Acevedo J, Duran-Guell M, Nunez L, Costa M, Torres M, Horrillo R, Ruiz-Del-Arbol L, Villanueva C, Prado V, Arteaga M, Trebicka J, Angeli P, Merli M, Alessandria C, Aagaard NK, Soriano G, Durand F, Gerbes A, Gustot T, Welzel TM, Salerno F, Banares R, Vargas V, Albillos A, Silva A, Morales-Ruiz M, Carlos Garcia-Pagan J, Pavesi M, Jalan R, Bernardi M, Moreau R, Paez A, Arroyo V. Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis. Gastroenterology. 2019 Jul;157(1):149-162. doi: 10.1053/j.gastro.2019.03.021. Epub 2019 Mar 22. |
| https://www.medrxiv.org/content/10.1101/2024.06.12.24308846v1.full | View source |
| https://pubmed.ncbi.nlm.nih.gov/22732511/ | View source |
| https://pubmed.ncbi.nlm.nih.gov/23934414/ | View source |
| https://pubmed.ncbi.nlm.nih.gov/21484145/ | View source |
| https://pubmed.ncbi.nlm.nih.gov/32576140/ | View source |
| https://pubmed.ncbi.nlm.nih.gov/35120736/ | View source |