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NHS FORTH VALLEY

Guidelines for Use of Human Albumin Solution

Approved 24/01/10 Version 2.3 Date of First Issue 09/06/2008 Review Date 30/06/2016 Date of Issue 01/07/2014 EQIA Yes Author / Contact Dr Christopher Brammer, Consultant Haematologist Group / Committee Final Approval

NHS Forth Valley Hospital Transfusion Committee

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NHS Forth Valley Consultation and Change Record Contributing Authors: Dr David Watts

Dr Christopher Brammer Dr Martyn Hawkins Mr Stephen McBurney

Consultation Process:

Members of Hospital Transfusion Team; Hospital Transfusion Committee; Consultant Gastroenterologists; Intensive Care Consultants

Distribution:

Intranet

Change of Record

Date Author Nature of Change Reference

23.6.09 1.6.11 1.3.12 18.5.12

Dr C Brammer Dr C Brammer Dr C Brammer Dr C Brammer

Removal of reference to 500ml units of 4.5% HAS replacing with 500ml units of 4% HAS. Change to ordering procedure for HAS to reflect change from stock holding in Blood Bank to Pharmacy. Removal of reference to Human Albumin Solution 4.5% 100ml Removal of any reference to 4% HAS and replacement with 5% HAS. References to SRI removed and changed to FVRH. Change to SBP management HAS now given for confirmed SBP even if serum creatinine not rising.

Pages 4 and 5 Page 6 Page 6 Pages 4, 5 and 6 Page 6 Page 5

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Forth Valley Guidelines for the Usage of Human Albumin Solution (HAS) in the context of the clinical complications of chronic liver disease

Ascites and large volume paracentesis

o Ascites complicates 50% of all cirrhotic chronic liver disease over any 10 year period and this occurs typically in the setting of significant portal hypertension and salt and water retention (largely unrelated to plasma albumin)

o The onset of ascites in a patient with chronic liver disease is

associated with significant mortality (50% over 2 years) o Common causes of chronic liver disease include:

viral hepatitis alcoholic liver disease autoimmune liver disease e.g. PBC / PSC haemochromatosis NASH

o Where management of ascites is refractory to sodium restriction (90mmol / day) and diuretic Rx large volume paracentesis is often required.

o Beyond paracentesis, there is a resulting fall in pulmonary capillary

wedge pressure (PCWP) which is maximal at 6 hours. This fall in PCWP without fluid replacement results in circulatory and renal dysfunction and is inversely associated with survival.

Guidance for fluid replacement in large volume paracentesis: 1. Where there is normal premorbid renal function:

1 unit (100ml) HAS 20% (STAT) following every 3 litres of ascites drained.

2. Where renal function is impaired consider either:

a. 100ml HAS 20% per 2 litres of ascites

or b. adherence to protocol for hepatorenal syndrome (see below)

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Spontaneous bacterial peritonitis (SBP)

SBP is a common complication (10 30%) of hospitalized patients with ascites due to chronic liver disease and requires prompt diagnosis and initiation of appropriate antibiotic Rx (ceftriaxone / ciprofloxacin)

SBP will recur in 70% of patients over a 12 month period

Renal impairment occurs in 30% of patients with SBP

Development of renal failure is a strong predictor of mortality

Administration of HAS in SBP reduces the incidence of renal failure and mortality

Guidance for Human Albumin Solution in SBP:

For treatment of confirmed SBP:

Day 1

: 1.5g HAS / kg given over initial 6 hour period:

Day 3:

1g HAS / kg

E.g. for 80 kg man:

Day 1: 120g albumin

6 units (600ml) 20% HAS (20g / 100ml) Or

6 units (2500ml) 5% HAS (20g / 500ml)

Day 3: 80g albumin

4 units (400ml) 20% HAS (20g / 100ml) Or

4 units (1500ml) 5% HAS (20g / 500ml)

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Hepatorenal syndrome (HRS)

o HRS refers to acute renal failure that occurs in the setting of cirrhosis or fulminant liver failure associated with portal hypertension, usually in the absence of other disease of the kidney.[1][2]

o The pathology involved in the development of hepatorenal syndrome is thought to be an alteration in blood flow and blood vessel tone in the circulation that supplies the intestines (the splanchnic circulation) and the circulation that supplies the kidney.[3]

o It is usually indicative of the end-stage of pathologically reduced

perfusion, or blood flow to the kidney, due to deteriorating liver function.

o Occurs in up to 10% patients with cirrhotic liver disease

o Hepatorenal syndrome is associated with high mortality and, if

untreated, the condition is usually fatal.

o Treatment usually involves medical therapy or TIPS as a bridge to liver transplantation.[2]

o Administration of HAS and vasoconstrictors are effective Rx in 60%

of patients with HRS and associated with improved survival

Guidance for medical Rx in HRS: 1. Terlipressin: 0.5 2mg IV every 4 hours 2. Human albumin solution:

a . Day 1: 1g / kg HAS Either 20% HAS (20g /100ml) or 5% HAS (20g/500ml) b. Day 2 - 16: 20 40 g HAS / day Rx continued until serum creatinine falls below 130mol/l NB. Where creatinine is rising despite Rx, 60g HAS /day may be clinically indicated

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Requesting Human Albumin Solution: Human Albumin Solution (HAS) is available from the Hospital Pharmacy at Forth Valley Royal Hospital (FVRH) and is issued on a named patient basis to comply with UK blood transfusion guidelines and UK/EU Good Manufacturing Practice regulations. The products in stock are:

Human Albumin Solution 5.0% 500ml (approx 20g albumin) Human Albumin Solution 20% 100ml (approx 20g albumin)

For all the indications detailed above, clinical guidance is provided by the Consultant Gastroenterologists, who will indicate which of the above products, and how much, is required for each individual patient. Medical staff responsible for the care of the patient should then request HAS directly from the FVRH Pharmacy department by completing a pharmacy indent request, available on the ward, with the following information:

Full name, date of birth and CHI number for the patient Product required and volume (number of bottles) to be issued Location of patient and time when HAS is required

For all indications not included in these guidelines, the request will be redirected to the duty consultant haematologist for authorization. The Hospital Transfusion Committee will monitor and audit HAS issue and use. HAS will be issued from the pharmacy on a daily basis as required it is not appropriate to store HAS in the ward area. A small emergency stock of HAS will be held in ITU and the Pharmacy dept. emergency fridge (which the bed co-ordinator has access to). At the end of the clinical episode, any HAS which has not been infused to the named patient must be destroyed as clinical waste. It is not acceptable to infuse a product issued to a named patient into any other individual. References: 1.Arroyo V, Gines P, Gerbes AL, Dudley FJ, Gentilini P, Laffi G, Reynolds TB, Ring-Larsen H, Scholmerich J. Definition and diagnostic criteria of refractory ascites and hepatorenal syndrome in cirrhosis. International Ascites Club. Hepatology. 1996 Jan; 23(1):164-76. 2. Wong F, Blendis L. New challenge of hepatorenal syndrome: prevention and treatment. Hepatology 2001 Dec; 34(6):1242-51. 3. Arroyo V, Guevara M, Gines P. Hepatorenal syndrome in cirrhosis: pathogenesis and treatment. Gastroenterology 2002 May; 122(6):1658-76.

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Further references: British Society of Gastroenterology Guidelines for the management of ascites in cirrhosis. Gut 2006

http://www.bsg.org.uk/bsgdisp1.php?id=6831b1e0bcbd40a30f82&h=1&sh=1&i=1&b=1&m=00023

Gines et al. The management of ascites in adult patients with cirrhosis. N Engl J Med. 2004 Apr 15; 350(16):1646-54

.

Runyon BA et al Management of adult patients with ascites caused by cirrhosis Hepatology. 1998 Jan; 27(1):264-72

.

Runyon BA American Association for Study of Liver Disease Practice Guideline. Management of adult patients with ascites due to cirrhosis Hepatology 2004 39(3):1-16

https://www.aasld.org/eweb/docs/practiceguidelines/ascites.pdf

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Publications in Alternative Formats

NHS Forth Valley is happy to consider requests for publications in other language or formats such as large print. To request another language for a patient, please contact 01786 434784. For other formats contact 01324 590886, text 07990 690605, fax 01324 590867 or e-mail - fv-uhb.nhsfv-alternativeformats@nhs.net

Forth Valley Guidelines for the Usage of Human Albumin Solution (HAS) in the context of the clinical complications of chronic liver diseaseAscites and large volume paracentesisGuidance for fluid replacement in large volume paracentesis:

Spontaneous bacterial peritonitis (SBP)Guidance for Human Albumin Solution in SBP:

Hepatorenal syndrome (HRS)Guidance for medical Rx in HRS:Requesting Human Albumin Solution: