ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia

February 12, 2013 updated by: Christian Loubert, Maisonneuve-Rosemont Hospital
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.

Study Overview

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Voluven

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christian Loubert, MD, FRCPC, Maisonneuve-Rosemont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

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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