Voluven (Hydroxyethyl Starch) Administration: Do Not Use in Most Clinical Settings
Voluven (6% HES 130/0.4) is contraindicated in critically ill patients, including those with sepsis, renal dysfunction, or severe liver disease, and should not be used for volume replacement therapy in surgical patients. 1, 2, 3
Absolute Contraindications
The FDA drug label and current guidelines establish clear contraindications where Voluven must never be used: 3
- Critically ill adult patients, including those with sepsis - due to increased mortality and need for renal replacement therapy 2, 3
- Severe liver disease 2, 3
- Pre-existing renal dysfunction - avoid use and discontinue at first sign of renal injury 3
- Clinical conditions where volume overload is problematic (congestive heart failure, renal disease) 2, 3
- Pre-existing coagulation or bleeding disorders 2, 3
- Known hypersensitivity to hydroxyethyl starch 3
Evidence Against Use in Surgical Patients
The 2024 British Journal of Anaesthesia perioperative guidelines provide a strong recommendation against using synthetic colloids (including Voluven) for volume replacement therapy in surgical patients until new evidence emerges. 1 This recommendation is based on high-quality evidence showing no benefit over crystalloids and significant harm. 1
Dosing Protocol (If Used in Non-Contraindicated Settings)
If Voluven is used in the rare non-contraindicated patient requiring plasma volume expansion: 3
- Maximum dose: 50 mL/kg body weight per day 4
- Administration route: Intravenous infusion only 3
- Available concentration: 30 g hetastarch in 500 mL 0.9% sodium chloride 3
- Infusion rate: Typically administered over 30 minutes for volume expansion 5
Renal Monitoring Requirements
Critical monitoring protocol if Voluven is administered: 3
- Monitor renal function continuously during hospitalization 3
- Continue monitoring for at least 90 days post-administration - renal replacement therapy has been reported up to 90 days after HES use 3
- Discontinue immediately at first sign of renal injury 3
Evidence of Harm
The CHEST trial (7,000 patients) demonstrated that Voluven increased the need for renal replacement therapy (7.0% vs 5.8%, RR 1.21, P=0.04) compared to saline, with no mortality benefit. 6, 4 The European Medicines Agency recommended in 2013 that HES no longer be used for volume resuscitation, particularly in sepsis patients. 2, 7
Recommended Alternatives
Use balanced crystalloids (lactated Ringer's or Plasma-Lyte) as first-line therapy for volume resuscitation: 1, 8
- Administer at least 30 mL/kg within first 3 hours for sepsis 8
- Aim for 1-2 L positive balance by end of surgery to protect renal function 1
- Balanced crystalloids reduce risk of acute kidney injury compared to 0.9% saline 1, 7
Special Situations to Avoid
Do not use Voluven: 3
- As cardiac bypass pump prime 3
- During cardiopulmonary bypass 3
- In immediate post-bypass period (increased coagulation abnormalities and bleeding risk) 3
Common Adverse Events
Voluven causes significantly more adverse events than crystalloids (5.3% vs 2.8%, P<0.001), predominantly: 6, 4