Comparison of 5% human albumin and normal saline for fluid resuscitation in sepsis induced hypotension among patients with cirrhosis (FRISC study): a randomized controlled trial.

Abstract

AIMS:

Sepsis and septic shock are common causes of hospitalization and mortality in patients with cirrhosis. There is no data on the choice of fluid and resuscitation protocols in sepsis-induced hypotension in cirrhosis.

METHODS:

In this open-label trial conducted at a single center, we enrolled 308 cirrhotics with sepsis-induced hypotension and randomized them to receive either 5% albumin or normal saline. The primary endpoint was a reversal of hypotension [mean arterial pressure, MAP, ≥ 65 mmHg] at 3 h. Secondary endpoints included serial effects on heart rate, arterial lactate and urine output.

RESULTS:

154 patients each received 5% albumin (males, 79.8%, mean MAP 52.9 ± 7.0 mm Hg) or 0.9% saline (85.1%, 53.4 ± 6.3 mm Hg) with comparable baseline parameters and liver disease severity. Reversal of hypotension was higher in patients receiving 5% albumin than saline at the end of one hour [25.3% and 11.7%, p = 0.03, Odds ratio (95% CI)-1.9 (1.08-3.42)] and at the end of three hours [11.7% and 3.2%, p = 0.008, 3.9 (1.42-10.9)]. Sustained reduction in heart rate and hyperlactatemia (p < 0.001) was better in the albumin group. At one week, the proportion of patients surviving was higher in the albumin group than those receiving saline (43.5% vs 38.3%, p = 0.03). Female gender and SOFA ≥ 11 were predictors of non-response to fluid.

CONCLUSIONS:

5% human albumin is safe and beneficial in reversing sepsis-induced hypotension compared to normal saline in patients with cirrhosis improving clinically assessable parameters of systemic hemodynamics, tissue perfusion and in-hospital short-term survival of cirrhosis patients with sepsis.

• Authors: Cyriac Abby Philips, Rakhi Maiwall, Manoj Kumar Sharma, Ankur Jindal, Ashok Kumar Choudhury, Guresh Kumar, Ankit Bhardwaj, Lalita Gouri Mitra, Prashant Mohan Agarwal, Shiv Kumar Sarin
• Journal: Hepatology international (Hepatol Int) Vol. 15 Issue 4 Pg. 983-994 (Aug 2021) ISSN: 1936-0541 [Electronic] United States
• PMID: 34036519 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: © 2021. Asian Pacific Association for the Study of the Liver.

Chemical References

• Saline Solution
• Serum Albumin, Human

Topics

• Female
• Humans
• Hypotension, Controlled
• Liver Cirrhosis (complications)
• Male
• Saline Solution
• Sepsis (complications, therapy)
• Serum Albumin, Human