ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 15, 2013
February 1, 2013
1.7 years
August 10, 2011
February 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume of HES which will prevent hypotension if 50 % of the subjects.
4 months
Secondary Outcomes (6)
Incidence of hypotension episodes
1 hour
Incidence of hypertensive episodes
1 hour
cardiac output
1 hour
Apgar score
10 minutes
umbilical artery pH
2 hours
- +1 more secondary outcomes
Study Arms (1)
Hydroxyethylstarch 130/0.4
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Healthy pregnant women (ASA I or II)
- Normal pregnancy
- Term gestation (37 weeks and above)
- Elective cesarean section
- Spinal anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maisonneuve-Rosemont Hospitallead
- Université de Montréalcollaborator
Study Sites (1)
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Loubert, MD, FRCPC
Maisonneuve-Rosemont Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
October 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 15, 2013
Record last verified: 2013-02