Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section - Full Text View

Sponsor:	Fresenius Kabi
Information provided by:	Fresenius Kabi
ClinicalTrials.gov Identifier:	NCT00694343

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 IV

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:

MedlinePlus related topics: Cesarean Section Low Blood Pressure

Drug Information available for: Lactic acid Chlorides Ammonium lactate Sodium chloride Ringer's lactate Ringer's lactate solution

U.S. FDA Resources

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:	169
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

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:	Dr. Joachim Schuetze, Fresenius Kabi Deutschland GmbH
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:	March 8, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Fresenius Kabi:

Cesarean section
spinal anesthesia
hypotension

Additional relevant MeSH terms:

Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012