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Acute Liver Failure in the USA: Results of the US ALF Study Group. William M. Lee, MD Meredith Mosle Distinguished Professor in Liver Disease University of Texas Southwestern Medical Center Dallas, TX www3.utsouthwestern.edu/liver. Acute Liver Failure (ALF): Definition. Altered mentation

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acute liver failure in the usa results of the us alf study group

Acute Liver Failure in the USA: Results of the US ALF Study Group

William M. Lee, MD

Meredith Mosle Distinguished Professor in Liver Disease

University of Texas Southwestern Medical Center Dallas, TX

www3.utsouthwestern.edu/liver

acute liver failure alf definition
Acute Liver Failure (ALF): Definition
  • Altered mentation
  • Coagulopathy (INR >1.5)
  • Acute illness (< 26 wks)
  • No cirrhosis
  • Variety of etiologies
acute liver failure alf background
Acute Liver Failure (ALF) Background
  • Orphan disease: ca. 2,000 cases/yr
  • No one center can study the condition
  • No viable treatment for all patients
  • High mortality/morbidity
  • Transplantation has helped--how much?
acute liver failure study group a consortium to study a rare disease
Acute Liver Failure Study GroupA consortium to study a rare disease
  • 14 academic med centers initially in 1998, now 25
  • Also 23 pediatric sites, since 2000
  • Detailed prospective data and serum samples
  • N-acetylcysteine trial for non-ACM ALF
  • Numerous ancillary studies in progress

Funded by NIH R03, FDA Orphan Grant, NIH R01 (‘00-’05)

alf etiologies prior us studies
ALF etiologies: prior US studies (%)

* ‘Infectious and serum hepatitis’

Medicine 1969;48:151-72, Dig Dis Sci 1991;36:1223-8, Mayo Clin Proc 1985;60:289-92, Liver Transpl Surg 1999;5:29-34, and Liver Transpl 2000;6:163-9.

slide9

Comparison Between Retrospective Study (1994-96; n = 295) and Current Study (1998-2001; n = 308)

+ NS

slide10

Comparison of Different ALF Etiology Groups

Variable Acetaminophen Drug Induced Indeterminate All Others p

(n = 120) (n = 40) (n = 53) (n = 95)value

Sex (%F) 79 73 60 72 NS

Age (yrs) 36 41 38 43 0.02

Jaundice (days) 1 12 12 4 <0.001

Coma III/IV (%) 50 43 47 47 NS

ALT 4310 574 947 1060 <0.001

Bilirubin 4.3 20.2 24.5 12.6 <0.001

Tx (%) 6 53 51 36<0.001

Spont surv (%) 68 25 17 33 <0.001

Overall surv (%) 73 70 64 61 NS

presentations of acetaminophen poisoning accidental vs suicidal cases
Presentations of acetaminophen poisoningAccidental vs. suicidal cases
  • Suicidal: single time point ingestion with suicidal intent
  • Accidental: multiple time points, cause for pain, suicidal intent denied
slide13

Acetaminophen Toxicity in an Urban County Hospital

The Parkland Study: Schiødt et al., NEJM 1997;337:1112-7

All patients admitted with potential ACM injury

Accidental Suicidal p-value

(n=21) (n=50)

Present >24h 64% 14% 0.001

EtOH abuse 63% 25% 0.009

ACM level mg/L 7 126 <0.001

ALT (IU/L) 7430 1501 0.001

ALT ≥1000 IU/L 62% 20% <0.002

Rec’d NAC 76% 80% 0.76

Hepatic coma 33% 6% <0.001

Death 19% 2% 0.04

slide14

Acetaminophen Toxicity Leading to ALF

Results in 108 patients, 12 deleted

  • Female 79%, median age 36 (19-63)
  • Alcohol use: 57%; alcohol abuse: 19%
  • Narcotic combinations: 38%
  • Dose ≥ 4 gm/day: 69%; ≥ 10 gm/day: 32%
  • ACM level detectable: 82%; > 50 mg/L: 42%
  • ALT > 7,000 IU/L: 51%; ALT > 3,500 IU/L: 92%
  • Cr ≥ 2.0 52%; pH ≤ 7.3 17%
slide15

Suicidal vs. Accidental ACM ALF Cases

Accidental Suicidal p-value

(n=59) (n=44)

Age 39 33 0.011

Tot ACM (g) 20 29 NS

Antidepress’t 36% 34% NS

EtOH 55% 61% NS

Double use 24% 5% 0.02

Narcotic/acet 54% 14% 0.001

ALT (IU/L) 3,616 5,929 <0.001

Creatinine 2.5 1.3 0.008

Survival 71% 75% NS

slide17

308 Patients enrolled

Transplanted

n= 89

(29%)

Died before

transplantation

n= 87

(28%)

Spontaneous

survivors

n= 132

(43%)

Alive

(n= 75)

Died

(n= 14)

Outcomes for Acute Liver Failure patients

Acetamin.: 30

Indetermin: 20

Drug-induced: 9

Shock liver: 7

Hepatitis B: 4

Malignancy: 4

Pregnancy: 3

Autoimm. hep.: 3

Wilson: 2

Hepatitis A: 2

Budd-Chiari: 1

Others: 2

slide18

Summary: Acetaminophen-related ALFConstitutes 1/3 of all US ALF deaths

  • The most common cause for ALF and a (?growing) problem in US (~150-800/year in US)
  • Alcohol relationship less apparent
  • Accidental and suicidal cases similar clinically
  • Relatively low mortality cf. other ALF causes
  • Role of anti-depressants 35%, narcotics 38% and repeated daily dosing needs further attention
  • Pediatric cases also of concern (~20%)