OBJECTIVE: To study the renal effects (measured by creatininemia) of plasma volume expansion with a medium molecular weight hydroxyethyl starch in the newborn. DESIGN: A prospective, randomized, double-blinded, pilot study. PATIENTS: The study included 26 neonates weighing 690-4030 g (gestational age, 26-40 wks), without cardiac or renal failure or major hemostasis abnormalities and requiring a peripherally inserted central catheter for parenteral nutrition. SETTING:Pediatric and neonatal intensive care unit of a university-affiliated hospital. INTERVENTIONS: Plasma volume expansion was performed to facilitate insertion of the central catheter. After parental consent, neonates were randomly allocated to receive intravenous infusions at 10 mL.kg(-1) of 5% albumin or 6% hydroxyethyl starch 200/0.5. Sample size was calculated to detect an increase in mean creatininemia of >20 micromol.L(-1) (with alpha = 0.05, beta = 0.80). MEASUREMENTS AND MAIN RESULTS: No clinically or statistically significant differences were found between the two groups 6 hrs, 24 hrs, 48 hrs, and 7 days after plasma volume expansion. The study could detect an increase in creatininemia > or =20 micromol.L(-1) with a power of 80%. CONCLUSIONS: In 13 healthy neonates, plasma volume expansion with 10 mL.kg(-1) of 6% hydroxyethyl starch 200/0.5 does not increase creatininemia.
RCT Entities:
OBJECTIVE: To study the renal effects (measured by creatininemia) of plasma volume expansion with a medium molecular weight hydroxyethyl starch in the newborn. DESIGN: A prospective, randomized, double-blinded, pilot study. PATIENTS: The study included 26 neonates weighing 690-4030 g (gestational age, 26-40 wks), without cardiac or renal failure or major hemostasis abnormalities and requiring a peripherally inserted central catheter for parenteral nutrition. SETTING: Pediatric and neonatal intensive care unit of a university-affiliated hospital. INTERVENTIONS: Plasma volume expansion was performed to facilitate insertion of the central catheter. After parental consent, neonates were randomly allocated to receive intravenous infusions at 10 mL.kg(-1) of 5% albumin or 6% hydroxyethyl starch 200/0.5. Sample size was calculated to detect an increase in mean creatininemia of >20 micromol.L(-1) (with alpha = 0.05, beta = 0.80). MEASUREMENTS AND MAIN RESULTS: No clinically or statistically significant differences were found between the two groups 6 hrs, 24 hrs, 48 hrs, and 7 days after plasma volume expansion. The study could detect an increase in creatininemia > or =20 micromol.L(-1) with a power of 80%. CONCLUSIONS: In 13 healthy neonates, plasma volume expansion with 10 mL.kg(-1) of 6% hydroxyethyl starch 200/0.5 does not increase creatininemia.