Respiratory events with terlipressin and albumin in hepatorenal syndrome: A review and clinical guidance

Allegretti, Andrew S.; Subramanian, Ram; Francoz, Claire; Olson, Jody C.; Cárdenas, Andrés

doi:10.1111/liv.15367

Cited by 25 publications

(16 citation statements)

References 39 publications

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“…In the CONFIRM study, respiratory failure (including acute respiratory failure) was reported in 14% of patients treated with terlipressin compared with 5% of patients treated with placebo ( 14 ). It was hypothesized that several factors contributed to the higher incidence of these adverse events, including administration of a high, and possibly an excessive, amount of albumin ( 27 ). Patients with a high MELD score, a high ACLF grade, and multisystem organ dysfunction—as was the case in the subpopulation of patients admitted to the ICU—are at a higher risk of respiratory failure related to terlipressin therapy; as such, a corresponding warning is included in the FDA label ( 15 ).…”

Section: Discussionmentioning

confidence: 99%

“…Patients with a high MELD score, a high ACLF grade, and multisystem organ dysfunction—as was the case in the subpopulation of patients admitted to the ICU—are at a higher risk of respiratory failure related to terlipressin therapy; as such, a corresponding warning is included in the FDA label ( 15 ). An algorithm for close monitoring using regular pulse oximetry, clinical volume examination and urine output, and regular adjustments of terlipressin and albumin, was proposed to mitigate the safety risks in this patient population ( 27 ).…”

Section: Discussionmentioning

confidence: 99%

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Role of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Admitted to the ICU: A Substudy of the CONFIRM Trial

Karvellas

Subramanian

Olson

et al. 2023

Critical Care Explorations

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This study assessed the potential advantages of treating hepatorenal syndrome-acute kidney injury (HRS-AKI) with terlipressin versus placebo in the ICU setting. DESIGN:Patients were randomly assigned in a 2:1 ratio to receive terlipressin or placebo for up to 14 days. SETTING:A retrospective analysis of data from the phase III CONFIRM study. PARTICIPANTS:Adult patients with HRS-AKI admitted to the ICU. MAIN OUTCOMES AND MEASURES:In this substudy, we evaluated outcomes of the ICU stay and the need for organ support, including renal replacement therapy (RRT).RESULTS: Among 300 patients with HRS-AKI from the CONFIRM study, 45 were treated in the ICU (terlipressin, 31/199 [16%]; placebo, 14/101 [14%]). On ICU admission, baseline demographics were similar across treatment arms, including severity of liver dysfunction. Among patients alive at the end of the ICU stay, those randomized to terlipressin had a significantly shorter median length of ICU stay than placebo (4 vs 11 d; p < 0.001). Terlipressin-treated patients had a significantly larger improvement in renal function from baseline versus placebo (-0.7 vs +0.2 mg/dL; p = 0.001), including when accounting for the interaction between treatment and day-of-patient-admission to the ICU (-0.7 vs +0.9 mg/dL; p < 0.001). Cumulative requirement for RRT through day 90 was improved in the terlipressin arm versus placebo (10/31 [32%] vs 8/14 [57%]; p = 0.12), although not significantly. Of 13 patients who received a liver transplant, five out of five (100%) in the placebo arm needed RRT through day 90 versus five out of eight (63%) in the terlipressin arm. CONCLUSIONS:In this subanalysis of CONFIRM, patients admitted to the ICU with HRS-AKI who received terlipressin were more likely to achieve renal function improvement, based on serum creatinine changes by the end of treatment, and had significantly shorter lengths of ICU stay than patients randomized to the placebo arm.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Role of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Admitted to the ICU: A Substudy of the CONFIRM Trial

Karvellas

Subramanian

Olson

et al. 2023

Critical Care Explorations

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“…Terlipressin increases cardiac afterload and has cardiac depressive effects. This, combined with an increased preload from albumin infusion, can cause cardiac failure and pulmonary edema in susceptible patients (10). Therefore, it is important to know the patient's baseline pulmonary status before terlipressin treatment.…”

Section: Monitoringmentioning

confidence: 99%

Practical Management of HRS-AKI in the Era of Terlipressin: What the Gastroenterologist Needs to Know

Kwo

2023

Am J Gastroenterol

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“…Moreover, in a RCT testing the benefit of terlipressin added to albumin against placebo added to albumin (CONFIRM trial) [20], subjects treated with terlipressin and albumin had a higher incidence of respiratory failure. The mean total dose of albumin for both treatment arms (prior to randomization and during the trial) was ~ 500-600 g [21]. While the amount of albumin given in the ATTIRE and CONFIRM trial exceeded that recommended dosage for a 48-h trial, patients who fail a 48-h trial may go on to continue receiving more albumin as part of HRS-1 management.…”

Section: Volume Expansion For Hypovolemiamentioning

confidence: 99%

Management of AKI in Patients with Cirrhosis

Regner

Kanduri

2022

Curr Treat Options Gastro

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Purpose of Review The development of acute failure of the kidneys in the context of decompensated cirrhosis represents one of the most challenging scenarios in clinical medicine due to the severity and complexity of the coexistence of those 2 illnesses. Thus, managing those cases can be cumbersome. Recent Findings While the state of advanced cirrhosis and portal hypertension can lead to a unique type of acute kidney injury (AKI)—hepatorenal syndrome type 1 (HRS-1)—a number of other etiologies can cause AKI, such as prerenal or cardiorenal insults, acute tubular injury, and other parenchymal entities. As a result, medical management of AKI in cirrhosis should be dictated by the driving cause of AKI. Summary Intravenous albumin is the preferred volume expander for hypovolemic states. Decongestive therapies are indicated in tense ascites-associated abdominal compartment syndrome and/or cardiorenal syndrome type 1. Vasoconstrictor therapy aimed to a specific rise in mean arterial pressure constitutes the cornerstone of the management of HRS-1. Most tubular causes of AKI are managed with supportive care, whereas other tubulointerstitial and glomerular conditions may warrant other interventions such as drug discontinuation, immunosuppression, or antimicrobial/antiviral therapy. Ultimately, AKI unresponsive to medical management may progress, and patients may ultimately necessitate renal replacement therapy (RRT) to sustain life. However, RRT must be carefully considered in this patient population taking in consideration eligibility for liver transplantation, life expectancy, risks and morbidity associated with RRT, and patients’ wishes and those of their families or support network.

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Respiratory events with terlipressin and albumin in hepatorenal syndrome: A review and clinical guidance

Cited by 25 publications

References 39 publications

Role of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Admitted to the ICU: A Substudy of the CONFIRM Trial

Role of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Admitted to the ICU: A Substudy of the CONFIRM Trial

Practical Management of HRS-AKI in the Era of Terlipressin: What the Gastroenterologist Needs to Know

Management of AKI in Patients with Cirrhosis

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