Trial reportHepatology international2021
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.
Trial report in Hepatology international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 8 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
52 citing papers in PubMed, 8 syntheses or guidelines pooled it, 100 citations in OpenAlex.
- Hyper-oncotic albumin administration reduces mortality in acute Respiratory Distress Syndrome compared to crystalloid: a systematic review and meta-analysis.Annals of medicine · 2026Pooled it
- Albumin for people with liver cirrhosis and bacterial infections.The Cochrane database of systematic reviews · 2026Pooled it
- Mortality effect of albumin fluid resuscitation in adults with septic shock: a systematic review and dual frequentist-bayesian meta-analysis of randomised trials.Critical care (London, England) · 2026Pooled it
- Fluid resuscitation in adults with severe infection and sepsis: a systematic review and network meta-analysis.Frontiers in medicine · 2025Pooled it
- Guideline
- APASL clinical practice guidelines on the management of acute kidney injury in acute-on-chronic liver failure.Hepatology international · 2024Guideline
- European Society of Intensive Care Medicine clinical practice guideline on fluid therapy in adult critically ill patients. Part 1: the choice of resuscitation fluids.Intensive care medicine · 2024Guideline
- Use of human albumin infusion in cirrhotic patients: a systematic review and meta-analysis of randomized controlled trials.Hepatology international · 2022Pooled it
- Prognostic significance of the blood urea nitrogen-to-serum albumin ratio in patients with septic shock.Experimental and therapeutic medicine · 2026Article
- A global consensus on the critical care management of acute-on-chronic liver failure patients: the APASL ACLF Beijing Position Paper.Hepatology international · 2026Article
- KASL clinical practice guidelines for liver cirrhosis: Ascites and related complications 2026.Clinical and molecular hepatology · 2026Article
- Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock 2026.Intensive care medicine · 2026Article
- Acute-on-chronic liver failure: pathophysiological mechanisms and clinical management.Nature reviews. Gastroenterology & hepatology · 2026Review
- Hypovolemic Shock in the Setting of Third Spacing with Concentric Left Ventricular Hypertrophy: A Physiology-Guided Management of Fluid Resuscitation-Case Report and Literature Review.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026Article
- Albumin 20% in surgical and critically ill patients; a comprehensive review.Critical care (London, England) · 2026Review
- Early albumin infusion and mortality in elderly patients with sepsis based on analysis of the Medical Information Mart for Intensive Care-IV (MIMIC-IV) database.Journal of Zhejiang University. Science. B · 2026Article
- Impact of albumin infusion on 30-day mortality in ICU patients with acute-on-chronic liver failure: a retrospective cohort using MIMIC-IV database.Clinical and experimental medicine · 2026Article
- Use of Human Serum Albumin in Critically Ill Patients: A Narrative Review.Journal of clinical medicine · 2026Review
- The Physiology, Pathophysiology, and Clinical Implications of Fluid Resuscitation in Critically Ill Patients.Cureus · 2026Review
- Albumin administration and 28-day mortality in sepsis-induced myocardial injury: a propensity score-matched analysis.Frontiers in pharmacology · 2026Article
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsSepsis 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.
methodsIn 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.
results154 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.
conclusions5% 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.