HypotensionPhase 4CAESARNCT00694343
Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section
A Phase 4 study testing HES 130/0.4 (6%) in sodium chloride (solution for infusion) and Ringer's Lactate solution in people with Hypotension, run by Fresenius Kabi at 14 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- HES 130/0.4 (6%) in sodium chloride (solution for infusion) and Ringer's Lactate solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 14 sitesFrance
- Study dates
- Jun 2008to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cesarean section applying spinal anesthesia
- ≥ week 37 of gestation
- Singleton pregnancy
Who cannot join
- Suspicion of any hypertensive disease
- Parturient in labor
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation
Clermont-Ferrand, 63003
Höpital Louis-Mourier - Service d'Anesthesie
Colombes, 92701
Département d'Anesthésie-Réanimation - Centre Hospitalo-Universitaire de Bicêtre
Le Kremlin-Bicêtre, 94275
Hopital Jeanne de Flandre, CHU
Lille, 59037
CHU Hotel Dieu, Service Anesthesie
Lyon, 69002
Hopital Arnaud de Villeneuve - Service Anesthésie-Réanimation
Montpellier, 34295
Hopital de l'Archet, Service Anesthesie-Reanimation
Nice, 6200
Hopital Caremeau, CHU, Service Anesthesie
Nîmes, 30000
Hopital Cochin, Service Anesthesie-Reanimation Chirurgicale
Paris, 75014
Hôpital Armand-Trousseau, Service d'anesthésie-réanimation
Paris, 75571
Hopital Robert Debre, CHU, Service Anesthesie
Reims, 51100
Hopital Hautepierre, CHU, Service Reanimation Chirurgicale
Strasbourg, 6700
Hopital Foch,Service Anesthesie
Suresnes, 92150
Unité d'anesthésie - Maternité Paule de Viguier
Toulouse, 31059
About this study
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
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
Read the 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.
- Conditions
- Hypotension
- Being tested
- HES 130/0.4 (6%) in sodium chloride (solution for infusion), Ringer's Lactate solution
- Keywords
- Cesarean section, spinal anesthesia, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HES 130/0.4 (6%) in sodium chloride (solution for infusion)Drug
Also called Voluven®
500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution
Ringer's Lactate solutionDrug
Also called Ringer's Lactate
1000 mL Ringer's Lactate solution
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution Receives: Drug: HES 130/0.4 (6%) in sodium chloride (solution for infusion) |
| Group B | Active comparator | 1000 mL Ringer's Lactate solution Receives: Drug: Ringer's Lactate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
Measured: Time between induction of spinal anesthesia until delivery
Secondary outcomes (4)
Minimum of systolic blood pressure until delivery
Measured: between induction of anesthesia and delivery
Maternal heart rate between induction of anesthesia and delivery
Measured: between induction of anesthesia and delivery
Onset and duration of hypotension between induction of anesthesia and delivery
Measured: between induction of anesthesia and delivery
Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value
Measured: between induction of anesthesia and delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederic Mercier, Professor, Principal investigator, Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694343
- Sponsor's protocol ID
- 07-HE06-03
- Other IDs
- EudraCT no.:2007-006065-32
- Acronym
- CAESAR
- Status last verified
- May 2012
- First submitted
- 6 Jun 2008
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32619039Mercier 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.
PubMed 24970272
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00694343
- Acronym / sponsor ID
- CAESAR / 07-HE06-03
- Conditions
- Hypotension
- Keywords
- Cesarean section, spinal anesthesia, hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | 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 |
| Group B | Active comparator | Drug: Ringer's Lactate solution1000 mL Ringer's Lactate solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective cesarean section applying spinal anesthesia
- ≥ week 37 of gestation
- Singleton pregnancy
Key exclusion criteria (2 listed)
- Suspicion of any hypertensive disease
- Parturient in labor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HES 130/0.4 (6%) in sodium chloride (solution for infusion)Also: Voluven®500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution | Drug | Group A |
| Ringer's Lactate solutionAlso: Ringer's Lactate1000 mL Ringer's Lactate solution | Drug | Group B |
Primary outcome
Incidence of hypotension
Time frame: Time between induction of spinal anesthesia until delivery
4 secondary outcomes
Minimum of systolic blood pressure until delivery
Time frame: between induction of anesthesia and delivery
Maternal heart rate between induction of anesthesia and delivery
Time frame: between induction of anesthesia and delivery
Onset and duration of hypotension between induction of anesthesia and delivery
Time frame: between induction of anesthesia and delivery
Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value
Time frame: between induction of anesthesia and delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
- Derived from this study: PubMed 32619039Chooi 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.
- Derived from this study: PubMed 24970272Mercier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Mercier, Professor principal investigator
Hôpital Béclère, Service Anesthésie-Réanimation, 157 Rue de la Porte de Trivaux, 92140 Clamart, France
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HES 130/0.4 (6%) in sodium chloride (solution for infusion) and Ringer's Lactate solution in people with Hypotension, run by Fresenius Kabi at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: Time between induction of spinal anesthesia until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.