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

Sponsor

Fresenius Kabi (Industry)

Overall Status

Completed

CT.gov ID

NCT00694343

Collaborator

(none)

167

Enrollment

Locations

Arms

Duration (Months)

11.9

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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

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

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 Design

Study Type:

Interventional

Actual Enrollment :

167 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of hypotension [Time between induction of spinal anesthesia until delivery]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation	Clermont Ferrand	France	63003
2	Höpital Louis-Mourier - Service d'Anesthesie	Colombes	France	92701
3	Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre	Le-Kremlin-Bicêtre	France	94275
4	Hopital Jeanne de Flandre, CHU	Lille	France	59037
5	CHU Hotel Dieu, Service Anesthesie	Lyon	France	69002
6	Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation	Montpellier	France	34295
7	Hopital de l'Archet, Service Anesthesie-Reanimation	Nice	France	6200
8	Hopital Caremeau, CHU, Service Anesthesie	Nimes	France	30000
9	Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale	Paris	France	75014
10	Hôpital Armand-Trousseau, Service d'anesthésie-réanimation	Paris	France	75571
11	Hopital Robert Debre, CHU, Service Anesthesie	Reims	France	51100
12	Hopital Hautepierre, CHU, Service Reanimation Chirurgicale	Strasbourg	France	6700
13	Hopital Foch,Service Anesthesie	Suresnes	France	92150
14	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