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Fluid Coloading and the Incidence of Hypotension

Primary Purpose

Complications; Cesarean Section, Anesthesia; Adverse Effect, Spinal and Epidural, Other Fluid Overload

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Cristalloid and colloid coloading
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications; Cesarean Section focused on measuring Anaesthesia Spinal, Ephedrine, Fluid Therapy, Hypotension

Eligibility Criteria

19 Years - 46 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hakki Unlugenc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

No coloading (Group E)

Cristalloid (Lactated Ringer) Coloading

Colloid (HES) coloading

Arm Description

Placebo comparator

Cristalloid (Lactated Ringer's) Coloading (Group L)

Colloid (HES) coloading (Group C)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2012
Last Updated
January 14, 2014
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT01741610
Brief Title
Fluid Coloading and the Incidence of Hypotension
Official Title
Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Cesarean Section, Anesthesia; Adverse Effect, Spinal and Epidural, Other Fluid Overload
Keywords
Anaesthesia Spinal, Ephedrine, Fluid Therapy, Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No coloading (Group E)
Arm Type
Placebo Comparator
Arm Description
Placebo comparator
Arm Title
Cristalloid (Lactated Ringer) Coloading
Arm Type
Active Comparator
Arm Description
Cristalloid (Lactated Ringer's) Coloading (Group L)
Arm Title
Colloid (HES) coloading
Arm Type
Active Comparator
Arm Description
Colloid (HES) coloading (Group C)
Intervention Type
Biological
Intervention Name(s)
Cristalloid and colloid coloading
Other Intervention Name(s)
Cristalloid coloading (Group L), Colloid coloading (Group C), No coloading (Group E)Placebo Comparator
Intervention Description
Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator
Primary Outcome Measure Information:
Title
Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading
Description
The primary study endpoint was the ephedrine requirement (incidence of hypotension).
Time Frame
Four Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakki Unlugenc, Prof Dr
Organizational Affiliation
Cukurova University
Official's Role
Study Chair
Facility Information:
Facility Name
Hakki Unlugenc
City
Adana
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

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