NCT01741610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

November 15, 2012

Last Update Submit

January 14, 2014

Conditions

Complications; Cesarean SectionAnesthesia; Adverse Effect, Spinal and EpiduralOther Fluid Overload

Keywords

Anaesthesia SpinalEphedrineFluid TherapyHypotension

Outcome Measures

Primary Outcomes (1)

  • 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).

    Four Years

Study Arms (3)

No coloading (Group E)

PLACEBO COMPARATOR

Placebo comparator

Biological: Cristalloid and colloid coloading

Cristalloid (Lactated Ringer) Coloading

ACTIVE COMPARATOR

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

Biological: Cristalloid and colloid coloading

Colloid (HES) coloading

ACTIVE COMPARATOR

Colloid (HES) coloading (Group C)

Biological: Cristalloid and colloid coloading

Interventions

Cristalloid and colloid coloadingBIOLOGICAL

Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator

Also known as: Cristalloid coloading (Group L), Colloid coloading (Group C), No coloading (Group E)Placebo Comparator
Colloid (HES) coloadingCristalloid (Lactated Ringer) ColoadingNo coloading (Group E)

Eligibility Criteria

Age19 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • elective caesarean section under spinal anaesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hakki Unlugenc

Adana, 01330, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Hakki Unlugenc, Prof Dr

    Cukurova University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr.

Study Record Dates

First Submitted

November 15, 2012

First Posted

December 5, 2012

Study Start

October 1, 2008

Primary Completion

August 1, 2011

Study Completion

June 1, 2012

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

TU(1)