Official Title: “Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section”

The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2009

Intravenous fluid administration prior to spinal anesthesia for cesarean section is an established part of anesthetic practice for the prevention of maternal hypotension.

Systematic reviews of clinical data suggest the usefulness of administering colloids to decrease the incidence of hypotension This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. Ringer's lactate solution in prevention of hypotension during spinal anesthesia for elective cesarean section.

Intervention(s) in this Clinical Trial

• Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)
  • 500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
• Drug: Ringer's Lactate solution
  • 1000 mL Ringer's Lactate solution

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group A
  • 500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
• Active Comparator: Group B
  • 1000 mL Ringer's Lactate solution

Primary Measures

• Incidence of hypotension
  • Time Frame: Time between induction of spinal anesthesia until delivery
    Safety Issue?: No

Secondary Measures

• Minimum of systolic blood pressure until delivery
  • Time Frame: between induction of anesthesia and delivery
    Safety Issue?: No
• Maternal heart rate between induction of anesthesia and delivery
  • Time Frame: between induction of anesthesia and delivery
    Safety Issue?: No
• Onset and duration of hypotension between induction of anesthesia and delivery
  • Time Frame: between induction of anesthesia and delivery
    Safety Issue?: No
• Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value
  • Time Frame: between induction of anesthesia and delivery
    Safety Issue?: No

Inclusion Criteria:

• elective cesarean section applying spinal anesthesia
• ≥ week 37 of gestation
• Singleton pregnancy

Exclusion Criteria:

• Suspicion of any hypertensive disease
• Parturient in labor

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Fresenius Kabi

Overall Clinical Trial Officials and Contacts

Frederic Mercier, Professor Principal Investigator Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France  

Overall Contact: Joachim Schuetze, Dr. 49-0617-2686 Joachim.schuetze@fresenius-kabi.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00694343

Study ID Number: 07-HE06-03

ClinicalTrials.gov Identifier: NCT00694343

Health Authority: France: Afssaps - French Health Products Safety Agency