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
Hepatology international. 2021
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.
Different effects of fluid loading with saline, gelatine, hydroxyethyl starch or albumin solutions on acid-base status in the critically ill
Plos One. 2017;12((4)):e0174507.
INTRODUCTION Fluid administration in critically ill patients may affect acid-base balance. However, the effect of the fluid type used for resuscitation on acid-base balance remains controversial. METHODS We studied the effect of fluid resuscitation of normal saline and the colloids gelatine 4%, hydroxyethyl starch (HES) 6%, and albumin 5% on acid-base balance in 115 clinically hypovolemic critically ill patients during a 90 minute filling pressure-guided fluid challenge by a post-hoc analysis of a prospective randomized clinical trial. RESULTS About 1700 mL was infused per patient in the saline and 1500 mL in each of the colloid groups (P<0.001). Overall, fluid loading slightly decreased pH (P<0.001) and there was no intergroup difference. This mildly metabolic acidifying effect was caused by a small increase in chloride concentration and decrease in strong ion difference in the saline- and HES-, and an increase in (uncorrected) anion gap in gelatine- and albumin-loaded patients, independent of lactate concentrations. CONCLUSION In clinically hypovolemic, critically ill patients, fluid resuscitation by only 1500-1700 mL of normal saline, gelatine, HES or albumin, resulted in a small decrease in pH, irrespective of the type of fluid used. Therefore, a progressive metabolic acidosis, even with increased anion gap, should not be erroneously attributed to insufficient fluid resuscitation. TRIAL REGISTRATION ISRCTN Registry ISRCTN19023197.