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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Christian Loubert, Maisonneuve-Rosemont Hospital.
Recruitment status was:  Recruiting
Université de Montréal
Information provided by (Responsible Party):
Christian Loubert, Maisonneuve-Rosemont Hospital Identifier:
First received: August 10, 2011
Last updated: February 12, 2013
Last verified: February 2013
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.

Condition Intervention Phase
Obstetric Anesthesia
Spinal Anesthesia
Fluid Therapy
Cesarean Section
Drug: Hydroxyethylstarch 130/0.4
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia

Resource links provided by NLM:

Further study details as provided by Christian Loubert, Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Volume of HES which will prevent hypotension if 50 % of the subjects. [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydroxyethylstarch 130/0.4 Drug: 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 Name: Voluven

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01415284

Contact: Christian Loubert, MD, FRCPC 514.252.3426
Contact: Louis-Philippe Fortier, MD, FRCPC 514.252.3426

Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Christian Loubert, MD, FRCPC    514.252.3426   
Contact: Louis-Philippe Fortier, MD, FRCPC    514.252.3426   
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         
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Université de Montréal
Principal Investigator: Christian Loubert, MD, FRCPC Maisonneuve-Rosemont Hospital
  More Information

Responsible Party: Christian Loubert, Dr, Maisonneuve-Rosemont Hospital Identifier: NCT01415284     History of Changes
Other Study ID Numbers: LoubertHMR2011/01
Study First Received: August 10, 2011
Last Updated: February 12, 2013

Keywords provided by Christian Loubert, Maisonneuve-Rosemont Hospital:
Obstetric anesthesia
Spinal anesthesia
Fluid therapy
Cesarean section
cardiac output

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Hydroxyethyl Starch Derivatives
Central Nervous System Depressants
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes processed this record on May 25, 2017