- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01415284
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Christian Loubert, MD, FRCPC
- Phone Number: 514.252.3426
- Email: loubertch@yahoo.fr
Study Contact Backup
- Name: Louis-Philippe Fortier, MD, FRCPC
- Phone Number: 514.252.3426
- Email: lpfortier@mac.com
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Recruiting
- Maisonneuve-Rosemont Hospital
-
Contact:
- Christian Loubert, MD, FRCPC
- Phone Number: 514.252.3426
- Email: loubertch@yahoo.fr
-
Contact:
- Louis-Philippe Fortier, MD, FRCPC
- Phone Number: 514.252.3426
- Email: lpfortier@mac.com
-
Principal Investigator:
- Christian Loubert, MD, FRCPC
-
Sub-Investigator:
- Pierre-Olivier Gagnon, MD
-
Sub-Investigator:
- Louis-Philippe Fortier, MD, FRCPC
-
Sub-Investigator:
- Pierre Drolet, MD,FRCPC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy pregnant women (ASA I or II)
- Normal pregnancy
- Term gestation (37 weeks and above)
- Elective cesarean section
- Spinal anesthesia
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydroxyethylstarch 130/0.4
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Volume of HES which will prevent hypotension if 50 % of the subjects.
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Apgar score
Time Frame: 10 minutes
|
10 minutes
|
Incidence of hypotension episodes
Time Frame: 1 hour
|
1 hour
|
Incidence of hypertensive episodes
Time Frame: 1 hour
|
1 hour
|
cardiac output
Time Frame: 1 hour
|
1 hour
|
umbilical artery pH
Time Frame: 2 hours
|
2 hours
|
additional vasopressors administered
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LoubertHMR2011/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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