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Published in: Indian Journal of Gastroenterology 4/2023

08-07-2023 | Bacterial Peritonitis | Original Article

Tolerance of standard dose albumin infused over 6 hrs for treatment of spontaneous bacterial peritonitis—A randomized controlled trial

Authors: Pinakee Sunder Kar, Shantan Venishetty, Shalini Thapar Laroia, Ankur Jindal, Rakhi Maiwall, Arun Kumar Sood, Saggere Muralikrishna Shasthry, Vijayaraghavan Rajan, Vinod Arora, Ankit Bhardwaj, Guresh Kumar, Manoj Kumar

Published in: Indian Journal of Gastroenterology | Issue 4/2023

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Abstract

Background and Aims

Twenty per cent albumin (1.5 g/kg at diagnosis and 1 g/kg on day three, infused over six-hour duration) is recommended particularly in high-risk spontaneous bacterial peritonitis (SBP). Whether reduced dose albumin infusion is as effective as the standard dose albumin infusion is not clear. The aim of this study was to compare standard dose albumin infusion with reduced dose albumin infusion in acute kidney injury (AKI) development or progression in patients with cirrhosis and high-risk SBP.

Methods

Sixty-three patients were randomized to the standard dose albumin arm (n = 31) and reduced dose albumin arm (n = 32, 0.75 g/kg at diagnosis and 0.5 g/kg 48 h later). The albumin was infused over six-hour duration in both groups. When the patient developed respiratory distress, the albumin infusion was stopped and that dose (i.e. of day one or day three) was not restarted and no attempt was made to finish the whole dose of that day. However, the next dose was started at the pre-calculated infusion rate if there was no evidence of respiratory distress at the start of next infusion.

Results

All 31 patients in standard dose and two (6.25%) in the reduced dose group developed symptomatic circulatory overload (p < 0.001), with infusions being stopped prematurely. The actual albumin dose received on day one was similar in both groups and only slightly higher in the standard dose group on day three. Resolution of SBP, progression of AKI to higher stage, in-hospital mortality and 28 days' mortality were similar in both groups.

Conclusions

For treatment of SBP, standard dose albumin infusion (1.5 g/kg at diagnosis and 1 g/kg 48 hours later) infused over six hours is not tolerated by Indian patients. The effectiveness of standard dose albumin infused over more prolonged periods, as compared to reduced dose albumin, should be evaluated in further studies.

Trial registration

Clinical Trials.gov Identifier: NCT04273373.
Literature
1.
go back to reference Follo A, Llovet JM, Navasa M, et al. Renal impairment after spontaneous bacterial peritonitis in cirrhosis: incidence, clinical course, predictive factors and prognosis. Hepatology. 1994;20:1495–501.CrossRefPubMed Follo A, Llovet JM, Navasa M,  et al. Renal impairment after spontaneous bacterial peritonitis in cirrhosis: incidence, clinical course, predictive factors and prognosis. Hepatology. 1994;20:1495–501.CrossRefPubMed
2.
go back to reference Tandon P, Garcia-Tsao G. Renal dysfunction is the most important independent predictor of mortality in cirrhotic patients with spontaneous bacterial peritonitis. Clin Gastroenterol Hepatol. 2011;9:260–5.CrossRefPubMed Tandon P, Garcia-Tsao G. Renal dysfunction is the most important independent predictor of mortality in cirrhotic patients with spontaneous bacterial peritonitis. Clin Gastroenterol Hepatol. 2011;9:260–5.CrossRefPubMed
3.
go back to reference Chin-Dusting JP, Rasaratnam B, Jennings GL, Dudley FJ. Effect of fluoroquinolone on the enhanced nitric oxide-induced peripheral vasodilation seen in cirrhosis. Ann Intern Med. 1997;127:985–8.CrossRefPubMed Chin-Dusting JP, Rasaratnam B, Jennings GL, Dudley FJ. Effect of fluoroquinolone on the enhanced nitric oxide-induced peripheral vasodilation seen in cirrhosis. Ann Intern Med. 1997;127:985–8.CrossRefPubMed
4.
go back to reference Navasa M, Follo A, Filella X, et al. Tumor necrosis factor and interleukin-6 in spontaneous bacterial peritonitis in cirrhosis: relationship with the development of renal impairment and mortality. Hepatology. 1998;27:1227–32.CrossRefPubMed Navasa M, Follo A, Filella X,  et al. Tumor necrosis factor and interleukin-6 in spontaneous bacterial peritonitis in cirrhosis: relationship with the development of renal impairment and mortality. Hepatology. 1998;27:1227–32.CrossRefPubMed
5.
go back to reference Evans TW. Albumin as a drug - biological effects of albumin unrelated to oncotic pressure. Aliment Pharmacol Ther. 2002;16 Suppl 5:6–11.CrossRefPubMed Evans TW. Albumin as a drug - biological effects of albumin unrelated to oncotic pressure. Aliment Pharmacol Ther. 2002;16 Suppl 5:6–11.CrossRefPubMed
6.
go back to reference European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69:406–60.CrossRef European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69:406–60.CrossRef
7.
go back to reference Biggins SW, Angeli P, Garcia-Tsao G, et al. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021;74:1014–48.CrossRefPubMed Biggins SW, Angeli P, Garcia-Tsao G, et al. Diagnosis, evaluation, and management of ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021;74:1014–48.CrossRefPubMed
8.
go back to reference Fernández J, Monteagudo J, Bargallo X, et al. A randomized unblinded pilot study comparing albumin versus hydroxyethyl starch in spontaneous bacterial peritonitis. Hepatology. 2005;42:627–34.CrossRefPubMed Fernández J, Monteagudo J, Bargallo X, et al. A randomized unblinded pilot study comparing albumin versus hydroxyethyl starch in spontaneous bacterial peritonitis. Hepatology. 2005;42:627–34.CrossRefPubMed
9.
go back to reference Sort P, Navasa M, Arroyo V, et al. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. N Engl J Med. 1999;341:403–9.CrossRefPubMed Sort P, Navasa M, Arroyo V, et al. Effect of intravenous albumin on renal impairment and mortality in patients with cirrhosis and spontaneous bacterial peritonitis. N Engl J Med. 1999;341:403–9.CrossRefPubMed
10.
go back to reference de Araujo A, de Barros LA, Rossi G, et al. Low-dose albumin in the treatment of spontaneous bacterial peritonitis: should we change the standard treatment? Gut. 2012;61:1371–2.CrossRefPubMed de Araujo A, de Barros LA, Rossi G, et al. Low-dose albumin in the treatment of spontaneous bacterial peritonitis: should we change the standard treatment? Gut. 2012;61:1371–2.CrossRefPubMed
11.
go back to reference Maroto A, Gines A, Salo J, et al. Diagnosis of functional kidney failure of cirrhosis with Doppler sonography: prognostic value of resistive index. Hepatology. 1994;20:839–44.CrossRefPubMed Maroto A, Gines A, Salo J,  et al. Diagnosis of functional kidney failure of cirrhosis with Doppler sonography: prognostic value of resistive index. Hepatology. 1994;20:839–44.CrossRefPubMed
12.
go back to reference Angeli P, Gines P, Wong F, et al. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Gut. 2015;64:531–7.CrossRefPubMed Angeli P, Gines P, Wong F, et al. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Gut. 2015;64:531–7.CrossRefPubMed
13.
go back to reference Angeli P, Garcia-Tsao G, Nadim MK, Parikh CR. News in pathophysiology, definition and classification of hepatorenal syndrome: a step beyond the International Club of Ascites (ICA) consensus document. J Hepatol. 2019;71:811–22.CrossRefPubMed Angeli P, Garcia-Tsao G, Nadim MK, Parikh CR. News in pathophysiology, definition and classification of hepatorenal syndrome: a step beyond the International Club of Ascites (ICA) consensus document. J Hepatol. 2019;71:811–22.CrossRefPubMed
14.
go back to reference Shasthry SM, Kumar M, Khumuckham JS, Sarin SK. Changes in cardiac output and incidence of volume overload in cirrhotics receiving 20% albumin infusion. Liver Int. 2017;37:1167–76.CrossRefPubMed Shasthry SM, Kumar M, Khumuckham JS, Sarin SK. Changes in cardiac output and incidence of volume overload in cirrhotics receiving 20% albumin infusion. Liver Int. 2017;37:1167–76.CrossRefPubMed
16.
go back to reference Scatchard G, Batchelder AC, Brown A. Chemical, clinical, and immunological studies on the products of human plasma fractionation. VI. The osmotic pressure of plasma and of serum albumin. J Clin Invest. 1944;23:458–64.CrossRefPubMedPubMedCentral Scatchard G, Batchelder AC, Brown A. Chemical, clinical, and immunological studies on the products of human plasma fractionation. VI. The osmotic pressure of plasma and of serum albumin. J Clin Invest. 1944;23:458–64.CrossRefPubMedPubMedCentral
17.
go back to reference Hubbard RW, Matthew WT, Horstman D, Francesconi R, Mager M, Sawka MN. Albumin-induced plasma volume expansion: diurnal and temperature effects. J Appl Physiol Respir Environ Exerc Physiol. 1984;56:1361–8.PubMed Hubbard RW, Matthew WT, Horstman D, Francesconi R, Mager M, Sawka MN. Albumin-induced plasma volume expansion: diurnal and temperature effects. J Appl Physiol Respir Environ Exerc Physiol. 1984;56:1361–8.PubMed
18.
go back to reference Santhanakrishnan R, Chan MM, Nyunt SZ, et al. Electrocardiographic criteria for left ventricular hypertrophy in Asians differs from criteria derived from Western populations—community-based data from an Asian population. Ann Acad Med Singap. 2015;44:274-83.CrossRefPubMed Santhanakrishnan R, Chan MM, Nyunt SZ, et al. Electrocardiographic criteria for left ventricular hypertrophy in Asians differs from criteria derived from Western populations—community-based data from an Asian population. Ann Acad Med Singap. 2015;44:274-83.CrossRefPubMed
19.
go back to reference Wang J, Thornton JC, Russell M, Burastero S, Heymsfield S, Pierson RN Jr. Asians have lower body mass index (BMI) but higher percent body fat than do whites: comparisons of anthropometric measurements. Am J Clin Nutr. 1994;60:23–8.CrossRefPubMed Wang J, Thornton JC, Russell M, Burastero S, Heymsfield S, Pierson RN Jr. Asians have lower body mass index (BMI) but higher percent body fat than do whites: comparisons of anthropometric measurements. Am J Clin Nutr. 1994;60:23–8.CrossRefPubMed
20.
go back to reference Davenport A, Hussain Sayed R, Fan S. The effect of racial origin on total body water volume in peritoneal dialysis patients. Clin J Am Soc Nephrol. 2011;6:2492–8.CrossRefPubMedPubMedCentral Davenport A, Hussain Sayed R, Fan S. The effect of racial origin on total body water volume in peritoneal dialysis patients. Clin J Am Soc Nephrol. 2011;6:2492–8.CrossRefPubMedPubMedCentral
Metadata
Title
Tolerance of standard dose albumin infused over 6 hrs for treatment of spontaneous bacterial peritonitis—A randomized controlled trial
Authors
Pinakee Sunder Kar
Shantan Venishetty
Shalini Thapar Laroia
Ankur Jindal
Rakhi Maiwall
Arun Kumar Sood
Saggere Muralikrishna Shasthry
Vijayaraghavan Rajan
Vinod Arora
Ankit Bhardwaj
Guresh Kumar
Manoj Kumar
Publication date
08-07-2023
Publisher
Springer India
Published in
Indian Journal of Gastroenterology / Issue 4/2023
Print ISSN: 0254-8860
Electronic ISSN: 0975-0711
DOI
https://doi.org/10.1007/s12664-023-01389-x

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