Trial record 5 of 173 for:    Open Studies | "Cesarean Section"

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
  Purpose

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
Hypotension
Fluid Therapy
Cesarean Section
Drug: Hydroxyethylstarch 130/0.4
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Volume of HES which will prevent hypotension if 50 % of the subjects. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415284

Contacts
Contact: Christian Loubert, MD, FRCPC 514.252.3426 loubertch@yahoo.fr
Contact: Louis-Philippe Fortier, MD, FRCPC 514.252.3426 lpfortier@mac.com

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

No publications provided

Responsible Party: Christian Loubert, Dr, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01415284     History of Changes
Other Study ID Numbers: LoubertHMR2011/01
Study First Received: August 10, 2011
Last Updated: February 12, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Maisonneuve-Rosemont Hospital:
Obstetric anesthesia
Spinal anesthesia
Hypotension
Fluid therapy
Cesarean section
phenylephrine
cardiac output

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Hydroxyethyl Starch Derivatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Plasma Substitutes
Blood Substitutes
Hematologic Agents

ClinicalTrials.gov processed this record on September 30, 2014