Obstetric AnesthesiaPhase 4NCT01415284
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
A Phase 4 study testing Hydroxyethylstarch 130/0.4 in people with Obstetric Anesthesia and Spinal Anesthesia, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obstetric Anesthesia, Spinal Anesthesia, Hypotension
- What is being tested?
- Hydroxyethylstarch 130/0.4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Jun 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy pregnant women (ASA I or II)
- Normal pregnancy
- Term gestation (37 weeks and above)
- Elective cesarean section
- Spinal anesthesia
Who cannot join
- Cardiopathies
- Hypertensive disease/ pre-eclampsia / eclampsia
- Any contraindication to neuraxial anesthesia
- Patient refusal
- Body mass index > 30 at first antenatal visit and > 32 at cesarean section
- Twin pregnancy
- Known allergies to HES
- Emergency cesarean section
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Christian Loubert, MD, FRCPC, 514.252.3426, loubertch@yahoo.fr
Louis-Philippe Fortier, MD, FRCPC, 514.252.3426, lpfortier@mac.com
About this study
The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.
Read the detailed description
The incidence of spinal anesthesia-induced hypotension in pregnant women undergoing a cesarean section is high. A preoperative fluid bolus of undetermined volume is frequently administered to lower the incidence of maternal hypotension, with a somewhat poor efficacy. Recently, several investigations have shown that the use of a phenylephrine infusion after the induction of spinal anesthesia results in a significant reduction in hypotensive episodes. Given the high efficacy of this therapy (incidence of hypotension around 20%), it is possible to determine the effective volume of fluid which would prevent hypotension in 50% of the patients studied (ED50).
Healthy term pregnant women undergoing elective cesarean section under spinal anesthesia will be recruited in this trial. The spinal anesthesia regimen will be standardized and all subjects will receive a phenylephrine infusion. The fluid investigated is hydroxyethylstarch (HES) 130/0.4 (Volulyte(R)). The ED50 will be determined using an up-down sequential allocation method initially described by Dixon \& Massey. The determination of the HES ED50 will help the anesthesiologist in further treating maternal hypotension appropriately.
- Being tested
- Hydroxyethylstarch 130/0.4
- Keywords
- Obstetric anesthesia, Spinal anesthesia, Hypotension, Fluid therapy, Cesarean section, phenylephrine, cardiac output
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethylstarch 130/0.4Drug
Also called Voluven
first patient : 500 mL. Following volumes according to up-down sequential allocation, with increments or decrements of 100 mL. An absence of hypotension will lead to an decrement while a presence of hypotension will result in an increment.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyethylstarch 130/0.4 | Experimental | Not described Receives: Drug: Hydroxyethylstarch 130/0.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of HES which will prevent hypotension if 50 % of the subjects.
Measured: 4 months
Secondary outcomes (6)
Incidence of hypotension episodes
Measured: 1 hour
Incidence of hypertensive episodes
Measured: 1 hour
cardiac output
Measured: 1 hour
Apgar score
Measured: 10 minutes
umbilical artery pH
Measured: 2 hours
additional vasopressors administered
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric AnesthesiaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Principal investigator, Christian Loubert, Maisonneuve-Rosemont Hospital
- Investigators
- Christian Loubert, MD, FRCPC, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415284
- Sponsor's protocol ID
- LoubertHMR2011/01
- Status last verified
- Feb 2013
- First submitted
- 10 Aug 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT01415284
- Acronym / sponsor ID
- LoubertHMR2011/01
- Keywords
- Obstetric anesthesia, Spinal anesthesia, Hypotension, Fluid therapy, Cesarean section, phenylephrine, cardiac output
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 11 Aug 2011 (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 purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.
Detailed description
The incidence of spinal anesthesia-induced hypotension in pregnant women undergoing a cesarean section is high. A preoperative fluid bolus of undetermined volume is frequently administered to lower the incidence of maternal hypotension, with a somewhat poor efficacy. Recently, several investigations have shown that the use of a phenylephrine infusion after the induction of spinal anesthesia results in a significant reduction in hypotensive episodes. Given the high efficacy of this therapy (incidence of hypotension around 20%), it is possible to determine the effective volume of fluid which would prevent hypotension in 50% of the patients studied (ED50).
Healthy term pregnant women undergoing elective cesarean section under spinal anesthesia will be recruited in this trial. The spinal anesthesia regimen will be standardized and all subjects will receive a phenylephrine infusion. The fluid investigated is hydroxyethylstarch (HES) 130/0.4 (Volulyte(R)). The ED50 will be determined using an up-down sequential allocation method initially described by Dixon \& Massey. The determination of the HES ED50 will help the anesthesiologist in further treating maternal hypotension appropriately.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxyethylstarch 130/0.4 | Experimental | Drug: Hydroxyethylstarch 130/0.4 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy pregnant women (ASA I or II)
- Normal pregnancy
- Term gestation (37 weeks and above)
- Elective cesarean section
- Spinal anesthesia
Key exclusion criteria (8 listed)
- Cardiopathies
- Hypertensive disease/ pre-eclampsia / eclampsia
- Any contraindication to neuraxial anesthesia
- Patient refusal
- Body mass index > 30 at first antenatal visit and > 32 at cesarean section
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 |
|---|---|---|
| Hydroxyethylstarch 130/0.4Also: Voluvenfirst patient : 500 mL. Following volumes according to up-down sequential allocation, with increments or decrements of 100 mL. An absence of hypotension will lead to an decrement while a presence of hypotension will result in an increment. | Drug | Hydroxyethylstarch 130/0.4 |
Primary outcome
Volume of HES which will prevent hypotension if 50 % of the subjects.
Time frame: 4 months
6 secondary outcomes
Incidence of hypotension episodes
Time frame: 1 hour
Incidence of hypertensive episodes
Time frame: 1 hour
cardiac output
Time frame: 1 hour
Apgar score
Time frame: 10 minutes
umbilical artery pH
Time frame: 2 hours
additional vasopressors administered
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
Christian Loubert, MD, FRCPC principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxyethylstarch 130/0.4 in people with Obstetric Anesthesia and Spinal Anesthesia, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Loubert, MD, FRCPC (514.252.3426, loubertch@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of HES which will prevent hypotension if 50 % of the subjects. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2013.