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

May 30, 2012 updated by: Fresenius Kabi

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France, 63003
        • CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation
      • Colombes, France, 92701
        • Höpital Louis-Mourier - Service d'Anesthesie
      • Le-Kremlin-Bicêtre, France, 94275
        • Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre
      • Lille, France, 59037
        • Hopital Jeanne de Flandre, CHU
      • Lyon, France, 69002
        • CHU Hotel Dieu, Service Anesthesie
      • Montpellier, France, 34295
        • Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation
      • Nice, France, 6200
        • Hopital de l'Archet, Service Anesthesie-Reanimation
      • Nimes, France, 30000
        • Hopital Caremeau, CHU, Service Anesthesie
      • Paris, France, 75014
        • Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale
      • Paris, France, 75571
        • Hôpital Armand-Trousseau, Service d'anesthésie-réanimation
      • Reims, France, 51100
        • Hopital Robert Debre, CHU, Service Anesthesie
      • Strasbourg, France, 6700
        • Hopital Hautepierre, CHU, Service Reanimation Chirurgicale
      • Suresnes, France, 92150
        • Hopital Foch,Service Anesthesie
      • Toulouse, France, 31059
        • Unité d'anesthésie - Maternité Paule de Viguier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
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
Other Names:
  • Voluven®
ACTIVE_COMPARATOR: Group B
1000 mL Ringer's Lactate solution
Drug: Ringer's Lactate solution
1000 mL Ringer's Lactate solution
Other Names:
  • Ringer's Lactate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of hypotension
Time Frame: Time between induction of spinal anesthesia until delivery
Time between induction of spinal anesthesia until delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Minimum of systolic blood pressure until delivery
Time Frame: between induction of anesthesia and delivery
between induction of anesthesia and delivery
Maternal heart rate between induction of anesthesia and delivery
Time Frame: between induction of anesthesia and delivery
between induction of anesthesia and delivery
Onset and duration of hypotension between induction of anesthesia and delivery
Time Frame: between induction of anesthesia and delivery
between induction of anesthesia and delivery
Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value
Time Frame: between induction of anesthesia and delivery
between induction of anesthesia and delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (ESTIMATE)

June 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-HE06-03
  • EudraCT no.:2007-006065-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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