What is the recommended administration protocol for VOLUVEN (hydroxyethyl starch) in an adult patient with potential hypovolemia or shock?

Do Not Administer VOLUVEN (Hydroxyethyl Starch) - Use Crystalloids Instead

VOLUVEN (6% HES 130/0.4) should not be used for volume resuscitation in critically ill patients, including those with sepsis, shock, or hypovolemia, due to strong evidence of increased mortality and renal replacement therapy requirements. 1, 2, 3

Critical Contraindications (FDA-Mandated)

VOLUVEN is absolutely contraindicated in the following situations 3:

• Critically ill adult patients, including those with sepsis (increased mortality and need for renal replacement therapy)
• Severe liver disease
• Pre-existing renal dysfunction
• Clinical conditions where volume overload is a concern (congestive heart failure, renal disease)
• Pre-existing coagulation or bleeding disorders
• Known hypersensitivity to hydroxyethyl starch

Why VOLUVEN Should Not Be Used

Mortality Risk

• The Surviving Sepsis Campaign provides a strong recommendation against using hydroxyethyl starches for intravascular volume replacement in patients with sepsis or septic shock, based on high-quality evidence 1
• The 2022 French guidelines (SFAR/SFMU) issued a GRADE 1- recommendation (highest level of evidence against use) stating HES should not be used in sepsis or septic shock due to increased mortality and renal replacement therapy requirements 1

Renal Toxicity

• Multiple large randomized trials (VISEP, 6S, CHEST) demonstrated increased incidence of acute kidney injury and need for renal replacement therapy with HES compared to crystalloids 1, 4
• The European Medicines Agency recommended in 2013 that HES no longer be used for volume resuscitation, particularly in sepsis patients 1, 4
• Renal replacement therapy has been reported up to 90 days after HES administration, requiring prolonged monitoring 3

Coagulopathy

• HES impairs coagulation and platelet function, increasing bleeding risk 5, 4
• The FDA label warns against use in cardiac bypass surgery due to increased coagulation abnormalities and bleeding 3

Correct Fluid Administration Protocol

First-Line: Balanced Crystalloids

Administer balanced crystalloids (Ringer's lactate or Plasma-Lyte) as first-line therapy 1, 5, 2:

• Initial bolus: 30 mL/kg within the first 3 hours for patients with sepsis or shock 4, 2
• Target: 1-2 liters positive fluid balance by end of resuscitation to protect renal function 5, 2
• Limit 0.9% saline to maximum 1-1.5 liters to avoid hyperchloremic acidosis 5

Monitoring Parameters

• Dynamic parameters preferred: skin temperature, capillary refill time, serum lactate 1
• Target MAP: 60-65 mmHg 1
• Monitor renal function continuously and for at least 90 days if HES was inadvertently given 3

If Crystalloids Fail

Add vasopressors (norepinephrine as first-line) rather than switching to colloids 1:

• Norepinephrine: first-choice vasopressor 1
• Add vasopressin (up to 0.03 U/min) or epinephrine if MAP targets not met 1
• Consider albumin only after substantial crystalloid administration in specific circumstances (e.g., cirrhosis with sepsis-induced hypotension) 4

Critical Pitfall to Avoid

Do not use VOLUVEN based on outdated protocols or theoretical volume expansion benefits. The theoretical advantage of faster hemodynamic stabilization with colloids has been definitively invalidated by multiple large randomized trials showing either no benefit or actual harm compared to crystalloids 1. The 2020 COVID-19 guidelines, 2017 Surviving Sepsis Campaign, and 2022 French critical care guidelines all provide strong recommendations against HES use 1.