Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section
CAESAR
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
2 other identifiers
interventional
167
1 country
14
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2008
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 6, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMay 31, 2012
May 1, 2012
1.5 years
June 6, 2008
May 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of hypotension
Time between induction of spinal anesthesia until delivery
Secondary Outcomes (4)
Minimum of systolic blood pressure until delivery
between induction of anesthesia and delivery
Maternal heart rate between induction of anesthesia and delivery
between induction of anesthesia and delivery
Onset and duration of hypotension 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
between induction of anesthesia and delivery
Study Arms (2)
Group A
EXPERIMENTAL500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
Group B
ACTIVE COMPARATOR1000 mL Ringer's Lactate solution
Interventions
500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
1000 mL Ringer's Lactate solution
Eligibility Criteria
You may qualify if:
- elective cesarean section applying spinal anesthesia
- ≥ week 37 of gestation
- Singleton pregnancy
You may not qualify if:
- Suspicion of any hypertensive disease
- Parturient in labor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fresenius Kabilead
Study Sites (14)
CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation
Clermont-Ferrand, 63003, France
Höpital Louis-Mourier - Service d'Anesthesie
Colombes, 92701, France
Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre
Le Kremlin-Bicêtre, 94275, France
Hopital Jeanne de Flandre, CHU
Lille, 59037, France
CHU Hotel Dieu, Service Anesthesie
Lyon, 69002, France
Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation
Montpellier, 34295, France
Hopital de l'Archet, Service Anesthesie-Reanimation
Nice, 6200, France
Hopital Caremeau, CHU, Service Anesthesie
Nîmes, 30000, France
Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale
Paris, 75014, France
Hôpital Armand-Trousseau, Service d'anesthésie-réanimation
Paris, 75571, France
Hopital Robert Debre, CHU, Service Anesthesie
Reims, 51100, France
Hopital Hautepierre, CHU, Service Reanimation Chirurgicale
Strasbourg, 6700, France
Hopital Foch,Service Anesthesie
Suresnes, 92150, France
Unité d'anesthésie - Maternité Paule de Viguier
Toulouse, 31059, France
Related Publications (2)
Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD002251. doi: 10.1002/14651858.CD002251.pub4.
PMID: 32619039DERIVEDMercier FJ, Diemunsch P, Ducloy-Bouthors AS, Mignon A, Fischler M, Malinovsky JM, Bolandard F, Aya AG, Raucoules-Aime M, Chassard D, Keita H, Rigouzzo A, Le Gouez A; CAESAR Working Group. 6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial. Br J Anaesth. 2014 Sep;113(3):459-67. doi: 10.1093/bja/aeu103. Epub 2014 Jun 26.
PMID: 24970272DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic Mercier, Professor
Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2008
First Posted
June 10, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2009
Study Completion
June 1, 2010
Last Updated
May 31, 2012
Record last verified: 2012-05