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Completed

NCT Number: NCT00694343

Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

The aim of the study is to evaluate the efficacy of Voluven® in the prevention of maternal hypotension in women undergoing spinal anesthesia for cesarean section

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont Ferrand - Hotel Dieu, Service Anesthesie-Reanimation, Clermont-Ferrand, France

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About this study

Intravenous fluid administration prior to spinal anesthesia for cesarean section is an established part of anesthetic practice for the prevention of maternal hypotension. Systematic reviews of clinical data suggest the usefulness of administering colloids to decrease the incidence of hypotension This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. Ringer's lactate solution in prevention of hypotension during spinal anesthesia for elective cesarean section.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective cesarean section applying spinal anesthesia
  • ≥ week 37 of gestation
  • Singleton pregnancy

Exclusion criteria

  • Suspicion of any hypertensive disease
  • Parturient in labor

Treatment and study plan

HES 130/0.4 (6%) in sodium chloride (solution for infusion)

Drug

500 mL of HES 130/0.4 (6%) and 500 mL Ringer's Lactate Solution

Other names: Voluven®

Ringer's lactate solution

Drug

1000 mL Ringer's Lactate solution

Other names: Ringer's Lactate

Primary outcomes

  1. Incidence of hypotension

    Time frame: Time between induction of spinal anesthesia until delivery

Secondary outcomes

  1. Minimum of systolic blood pressure until delivery

    Time frame: between induction of anesthesia and delivery

  2. Maternal heart rate between induction of anesthesia and delivery

    Time frame: between induction of anesthesia and delivery

  3. Onset and duration of hypotension between induction of anesthesia and delivery

    Time frame: between induction of anesthesia and delivery

  4. Phenylephrine requirements to keep systolic blood pressure equal or higher than 95% of baseline value

    Time frame: between induction of anesthesia and delivery

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

Evaluation of the Efficacy of 6% Hydroxyethyl Starch (HES, 130/0.4) in Normal Saline Compared to Ringer's Lactate Solution for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section

Acronym: CAESAR

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jun 10, 2008
Registry last updated
May 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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