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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00694343
First received: June 6, 2008
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Hypotension
Drug: HES 130/0.4 (6%) in sodium chloride (solution for infusion)
Drug: Ringer's Lactate solution
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Incidence of hypotension [ Time Frame: Time between induction of spinal anesthesia until delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minimum of systolic blood pressure until delivery [ Time Frame: between induction of anesthesia and delivery ] [ Designated as safety issue: No ]
  • Maternal heart rate between induction of anesthesia and delivery [ Time Frame: between induction of anesthesia and delivery ] [ Designated as safety issue: No ]
  • Onset and duration of hypotension between induction of anesthesia and delivery [ Time Frame: between induction of anesthesia and delivery ] [ Designated as 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 ] [ Designated as safety issue: No ]

Enrollment: 167
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Voluven®
Active Comparator: Group B
1000 mL Ringer's Lactate solution
Drug: Ringer's Lactate solution
1000 mL Ringer's Lactate solution
Other Name: Ringer's Lactate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Suspicion of any hypertensive disease
  • Parturient in labor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694343

Locations
France
CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation
Clermont Ferrand, France, 63003
Höpital Louis-Mourier - Service d'Anesthesie
Colombes, France, 92701
Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre
Le-Kremlin-Bicêtre, France, 94275
Hopital Jeanne de Flandre, CHU
Lille, France, 59037
CHU Hotel Dieu, Service Anesthesie
Lyon, France, 69002
Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation
Montpellier, France, 34295
Hopital de l'Archet, Service Anesthesie-Reanimation
Nice, France, 6200
Hopital Caremeau, CHU, Service Anesthesie
Nimes, France, 30000
Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale
Paris, France, 75014
Hôpital Armand-Trousseau, Service d'anesthésie-réanimation
Paris, France, 75571
Hopital Robert Debre, CHU, Service Anesthesie
Reims, France, 51100
Hopital Hautepierre, CHU, Service Reanimation Chirurgicale
Strasbourg, France, 6700
Hopital Foch,Service Anesthesie
Suresnes, France, 92150
Unité d'anesthésie - Maternité Paule de Viguier
Toulouse, France, 31059
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Frederic Mercier, Professor Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France
  More Information

No publications provided

Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT00694343     History of Changes
Other Study ID Numbers: 07-HE06-03, EudraCT no.:2007-006065-32
Study First Received: June 6, 2008
Last Updated: May 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Fresenius Kabi:
Cesarean section
spinal anesthesia
hypotension

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Pharmaceutical Solutions
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014