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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Maisonneuve-Rosemont Hospital
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Christian Loubert, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT01415284
First received: August 10, 2011
Last updated: February 12, 2013
Last verified: February 2013

August 10, 2011
February 12, 2013
October 2011
June 2013   (final data collection date for primary outcome measure)
Volume of HES which will prevent hypotension if 50 % of the subjects. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01415284 on ClinicalTrials.gov Archive Site
  • Incidence of hypotension episodes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Incidence of hypertensive episodes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • cardiac output [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Apgar score [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
  • umbilical artery pH [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • additional vasopressors administered [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Incidence of hypotension episodes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Incidence of hypertensive episodes [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • cardiac output [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Apgar score [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
  • umbilical artery pH [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • additionnal vasopresors administered [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obstetric Anesthesia
  • Spinal Anesthesia
  • Hypotension
  • Fluid Therapy
  • Cesarean Section
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
Experimental: Hydroxyethylstarch 130/0.4
Intervention: Drug: Hydroxyethylstarch 130/0.4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Christian Loubert, MD, FRCPC 514.252.3426 loubertch@yahoo.fr
Contact: Louis-Philippe Fortier, MD, FRCPC 514.252.3426 lpfortier@mac.com
Canada
 
NCT01415284
LoubertHMR2011/01
No
Christian Loubert, Maisonneuve-Rosemont Hospital
Maisonneuve-Rosemont Hospital
Université de Montréal
Principal Investigator: Christian Loubert, MD, FRCPC Maisonneuve-Rosemont Hospital
Maisonneuve-Rosemont Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP