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Plasma Volume Expander

Hydroxyethylstarch 130/0.4 for Low Blood Pressure

Phase 4
Waitlist Available
Led By Christian Loubert, MD, FRCPC
Research Sponsored by Maisonneuve-Rosemont Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

Study 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.

Eligible Conditions
  • Low Blood Pressure
  • Fluid Therapy
  • Obstetric Anesthesia
  • Cesarean Section
  • Spinal Anesthesia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Volume of HES which will prevent hypotension if 50 % of the subjects.
Secondary outcome measures
Apgar score
Incidence of hypertensive episodes
Incidence of hypotension episodes
+3 more

Side effects data

From 2019 Phase 4 trial • 160 Patients • NCT03350217
16%
Intraprocedural Bleeding
1%
Delayed Bleed
1%
Abdominal Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hetastarch
Eleview

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hydroxyethylstarch 130/0.4Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Maisonneuve-Rosemont HospitalLead Sponsor
99 Previous Clinical Trials
36,293 Total Patients Enrolled
Université de MontréalOTHER
213 Previous Clinical Trials
102,691 Total Patients Enrolled
Christian Loubert, MD, FRCPCPrincipal InvestigatorMaisonneuve-Rosemont Hospital
2 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
Christian Loubert 2011. "ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01415284.
All > Anesthesia
~2 spots leftby Apr 2025
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