Fluid Coloading and the Incidence of Hypotension

January 14, 2014 updated by: Hakki Unlugenc, Cukurova University

Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading

This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.

Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.

Study Type

Interventional

Enrollment (Actual)

90

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 Locations

  • Turkey
      • Adana, Turkey, 01330
        • Hakki Unlugenc

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

19 years to 46 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • elective caesarean section under spinal anaesthesia

Exclusion Criteria:

  • Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,
  • Pregnancy preinduced hypertension,
  • Being in active labour or requiring emergency caesarean section,
  • Any contraindication to regional anaesthesia such as local infection or bleeding disorders.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: No coloading (Group E)
Placebo comparator
Biological: Cristalloid and colloid coloading
Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator
Other Names:
  • Cristalloid coloading (Group L)
  • Colloid coloading (Group C)
  • No coloading (Group E)Placebo Comparator
ACTIVE_COMPARATOR: Cristalloid (Lactated Ringer) Coloading
Cristalloid (Lactated Ringer's) Coloading (Group L)
Biological: Cristalloid and colloid coloading
Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator
Other Names:
  • Cristalloid coloading (Group L)
  • Colloid coloading (Group C)
  • No coloading (Group E)Placebo Comparator
ACTIVE_COMPARATOR: Colloid (HES) coloading
Colloid (HES) coloading (Group C)
Biological: Cristalloid and colloid coloading
Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator
Other Names:
  • Cristalloid coloading (Group L)
  • Colloid coloading (Group C)
  • No coloading (Group E)Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading
Time Frame: Four Years
The primary study endpoint was the ephedrine requirement (incidence of hypotension).
Four Years

Collaborators and Investigators

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

Sponsor

Cukurova University

Investigators

  • Study Chair: Hakki Unlugenc, Prof Dr, Çukurova University

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, 2008

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

December 1, 2012

First Posted (ESTIMATE)

December 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZLTNS97

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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