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

NCT ID: NCT00694343

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Hypotension

Keywords

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Cesarean section spinal anesthesia hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution

Group Type EXPERIMENTAL

HES 130/0.4 (6%) in sodium chloride (solution for infusion)

Intervention Type DRUG

500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution

Group B

1000 mL Ringer's Lactate solution

Group Type ACTIVE_COMPARATOR

Ringer's Lactate solution

Intervention Type DRUG

1000 mL Ringer's Lactate solution

Interventions

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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

Intervention Type DRUG

Ringer's Lactate solution

1000 mL Ringer's Lactate solution

Intervention Type DRUG

Other Intervention Names

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Voluven® Ringer's Lactate

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Suspicion of any hypertensive disease
* Parturient in labor
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Kabi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic Mercier, Professor

Role: PRINCIPAL_INVESTIGATOR

Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France

Locations

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CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation

Clermont-Ferrand, , France

Site Status

Höpital Louis-Mourier - Service d'Anesthesie

Colombes, , France

Site Status

Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Hopital Jeanne de Flandre, CHU

Lille, , France

Site Status

CHU Hotel Dieu, Service Anesthesie

Lyon, , France

Site Status

Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation

Montpellier, , France

Site Status

Hopital de l'Archet, Service Anesthesie-Reanimation

Nice, , France

Site Status

Hopital Caremeau, CHU, Service Anesthesie

Nîmes, , France

Site Status

Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale

Paris, , France

Site Status

Hôpital Armand-Trousseau, Service d'anesthésie-réanimation

Paris, , France

Site Status

Hopital Robert Debre, CHU, Service Anesthesie

Reims, , France

Site Status

Hopital Hautepierre, CHU, Service Reanimation Chirurgicale

Strasbourg, , France

Site Status

Hopital Foch,Service Anesthesie

Suresnes, , France

Site Status

Unité d'anesthésie - Maternité Paule de Viguier

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32619039 (View on PubMed)

Mercier 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.

Reference Type DERIVED
PMID: 24970272 (View on PubMed)

Other Identifiers

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EudraCT no.:2007-006065-32

Identifier Type: -

Identifier Source: secondary_id

07-HE06-03

Identifier Type: -

Identifier Source: org_study_id