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NCT00694343 Clinical Trial

Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

Hypotension Clinical Trial

— CAESAR  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00694343
Other study ID # 07-HE06-03
Secondary ID EudraCT no.:2007
Status Completed
Phase Phase 4
First received June 6, 2008
Last updated May 30, 2012
Start date June 2008
Est. completion date June 2010

Study information
Verified date May 2012
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 167
Est. completion date June 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective cesarean section applying spinal anesthesia

- = week 37 of gestation

- Singleton pregnancy

Exclusion Criteria:

- Suspicion of any hypertensive disease

- Parturient in labor

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation Clermont Ferrand
France Höpital Louis-Mourier - Service d'Anesthesie Colombes
France Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre Le-Kremlin-Bicêtre
France Hopital Jeanne de Flandre, CHU Lille
France CHU Hotel Dieu, Service Anesthesie Lyon
France Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation Montpellier
France Hopital de l'Archet, Service Anesthesie-Reanimation Nice
France Hopital Caremeau, CHU, Service Anesthesie Nimes
France Hôpital Armand-Trousseau, Service d'anesthésie-réanimation Paris
France Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale Paris
France Hopital Robert Debre, CHU, Service Anesthesie Reims
France Hopital Hautepierre, CHU, Service Reanimation Chirurgicale Strasbourg
France Hopital Foch,Service Anesthesie Suresnes
France Unité d'anesthésie - Maternité Paule de Viguier Toulouse

Sponsors (1)
Lead Sponsor Collaborator
Fresenius Kabi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of hypotension Time between induction of spinal anesthesia until delivery No
Secondary Minimum of systolic blood pressure until delivery between induction of anesthesia and delivery No
Secondary Maternal heart rate between induction of anesthesia and delivery between induction of anesthesia and delivery No
Secondary Onset and duration of hypotension between induction of anesthesia and delivery between induction of anesthesia and delivery No
Secondary Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value between induction of anesthesia and delivery No
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