What is the proper administration protocol for VOLUVEN (hydroxyethyl starch) in a patient with potential hypovolemia or shock?

VOLUVEN Administration: Critical Safety Warning

Do NOT use VOLUVEN (hydroxyethyl starch) in critically ill patients, including those with sepsis, due to significantly increased risk of mortality and need for renal replacement therapy. 1, 2, 3, 4

Absolute Contraindications

VOLUVEN is contraindicated in the following patient populations 4:

• Critically ill adult patients, including sepsis - The FDA, European Medicines Agency, and multiple guideline societies have issued strong warnings against HES use in this population due to increased mortality 1, 3, 4
• Severe liver disease - Hepatic dysfunction contraindicates HES administration 1, 4
• Pre-existing renal dysfunction - Avoid in any patient with baseline kidney impairment 4
• Pre-existing coagulation or bleeding disorders - HES impairs coagulation function 1, 4
• Volume overload conditions - Including congestive heart failure and renal disease where fluid accumulation is problematic 1, 4
• Known hypersensitivity to hydroxyethyl starch 4
• Cardiac bypass surgery - Not recommended as pump prime or during/immediately after cardiopulmonary bypass 4

Evidence of Harm

The recommendation against VOLUVEN is based on high-quality evidence:

• The CHEST study demonstrated increased renal replacement therapy with relative risk of 1.17 in HES-treated patients compared to crystalloids 1
• Meta-analyses showed HES increased acute kidney injury risk (RR 1.60) without survival benefit in septic patients 5
• The 6S trial found increased mortality and need for renal replacement therapy with HES versus crystalloids 5

Recommended Alternatives for Fluid Resuscitation

Use balanced crystalloids as first-line therapy for volume resuscitation 1, 2, 3:

• Initial bolus: Administer at least 30 mL/kg of crystalloid (lactated Ringer's or Plasma-Lyte) within the first 3 hours for hypovolemia 3
• Pediatric dosing: Give 20 mL/kg boluses of isotonic crystalloid, repeating as needed if perfusion fails to improve 5
• Balanced crystalloids preferred over 0.9% saline - Reduces risk of acute kidney injury and metabolic acidosis 1, 3

When Colloids May Be Considered

If crystalloids alone are insufficient 5:

• Albumin may be considered for severe sepsis/septic shock after substantial crystalloid administration, particularly in patients with cirrhosis and sepsis-induced hypotension 5
• Albumin dosing: 20% albumin at 20g every 8 hours for 3 days has been studied in septic shock 5

Monitoring During Fluid Resuscitation

Continue fluid administration only while hemodynamic improvement is observed 5, 2:

• Dynamic monitoring: Assess stroke volume variation, pulse pressure variation, or passive leg raise response 5
• Static parameters: Monitor mean arterial pressure, heart rate, urine output, and central venous pressure 5
• Goal: Achieve adequate tissue perfusion without fluid overload 5

Critical Monitoring if VOLUVEN Was Already Administered

If HES products were given despite contraindications 4:

• Discontinue immediately at first sign of renal injury or coagulopathy 4
• Monitor renal function for at least 90 days post-administration, as need for renal replacement therapy has been reported up to 90 days after HES use 4
• Monitor liver function in all patients who received HES 4
• Assess coagulation status and discontinue at first sign of coagulopathy 4

Common Pitfall to Avoid

The most critical error is using VOLUVEN in septic or critically ill patients based on older literature showing hemodynamic benefits 6, 7, 8. While older studies demonstrated improved hemodynamics and cerebral oxygenation with HES, more recent high-quality trials have definitively shown increased mortality and renal failure that outweigh any short-term hemodynamic advantages 5, 1.