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

Primary Purpose

Hypotension

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

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

Ringer's Lactate solution

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Cesarean section, spinal anesthesia, hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation
Höpital Louis-Mourier - Service d'Anesthesie
Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre
Hopital Jeanne de Flandre, CHU
CHU Hotel Dieu, Service Anesthesie
Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation
Hopital de l'Archet, Service Anesthesie-Reanimation
Hopital Caremeau, CHU, Service Anesthesie
Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale
Hôpital Armand-Trousseau, Service d'anesthésie-réanimation
Hopital Robert Debre, CHU, Service Anesthesie
Hopital Hautepierre, CHU, Service Reanimation Chirurgicale
Hopital Foch,Service Anesthesie
Unité d'anesthésie - Maternité Paule de Viguier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

1000 mL Ringer's Lactate solution

Outcomes

Primary Outcome Measures

Incidence of hypotension

Secondary Outcome Measures

Minimum of systolic blood pressure until delivery

Maternal heart rate between induction of anesthesia and delivery

Onset and duration of hypotension between induction of anesthesia and delivery

Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value

Full Information

NCT ID

NCT00694343

First Posted

June 6, 2008

Last Updated

May 30, 2012

Sponsor

Fresenius Kabi

1. Study Identification

Unique Protocol Identification Number

NCT00694343

Brief Title

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

Acronym

CAESAR

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 Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fresenius Kabi

4. Oversight

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension

Keywords

Cesarean section, spinal anesthesia, hypotension

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

167 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

1000 mL Ringer's Lactate solution

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Voluven®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ringer's Lactate solution

Other Intervention Name(s)

Ringer's Lactate

Intervention Description

1000 mL Ringer's Lactate solution

Primary Outcome Measure Information:

Title

Incidence of hypotension

Time Frame

Time between induction of spinal anesthesia until delivery

Secondary Outcome Measure Information:

Title

Minimum of systolic blood pressure until delivery

Time Frame

between induction of anesthesia and delivery

Title

Maternal heart rate between induction of anesthesia and delivery

Time Frame

between induction of anesthesia and delivery

Title

Onset and duration of hypotension between induction of anesthesia and delivery

Time Frame

between induction of anesthesia and delivery

Title

Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value

Time Frame

between induction of anesthesia and delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic Mercier, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation

City

Clermont Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Höpital Louis-Mourier - Service d'Anesthesie

City

Colombes

ZIP/Postal Code

92701

Country

France

Facility Name

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

City

Le-Kremlin-Bicêtre

ZIP/Postal Code

94275

Country

France

Facility Name

Hopital Jeanne de Flandre, CHU

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

CHU Hotel Dieu, Service Anesthesie

City

Lyon

ZIP/Postal Code

69002

Country

France

Facility Name

Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Hopital de l'Archet, Service Anesthesie-Reanimation

City

Nice

ZIP/Postal Code

6200

Country

France

Facility Name

Hopital Caremeau, CHU, Service Anesthesie

City

Nimes

ZIP/Postal Code

30000

Country

France

Facility Name

Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Hôpital Armand-Trousseau, Service d'anesthésie-réanimation

City

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

Hopital Robert Debre, CHU, Service Anesthesie

City

Reims

ZIP/Postal Code

51100

Country

France

Facility Name

Hopital Hautepierre, CHU, Service Reanimation Chirurgicale

City

Strasbourg

ZIP/Postal Code

6700

Country

France

Facility Name

Hopital Foch,Service Anesthesie

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

Unité d'anesthésie - Maternité Paule de Viguier

City

Toulouse

ZIP/Postal Code

31059

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

32619039

Citation

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.

Results Reference

derived

PubMed Identifier

24970272

Citation

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.

Results Reference

derived

Learn more about this trial

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

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