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Fluid Coloading and the Incidence of Hypotension

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ClinicalTrials.gov Identifier: NCT01741610
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
Hakki Unlugenc, Cukurova University

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.

Condition or disease Intervention/treatment Phase
Complications; Cesarean Section Anesthesia; Adverse Effect, Spinal and Epidural Other Fluid Overload Biological: Cristalloid and colloid coloading Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   19 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741610


Locations
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Turkey
Hakki Unlugenc
Adana, Turkey, 01330
Sponsors and Collaborators
Cukurova University
Investigators
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Study Chair: Hakki Unlugenc, Prof Dr Cukurova University
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Responsible Party: Hakki Unlugenc, Prof Dr., Cukurova University
ClinicalTrials.gov Identifier: NCT01741610    
Other Study ID Numbers: HZLTNS97
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: January 15, 2014
Last Verified: January 2014
Keywords provided by Hakki Unlugenc, Cukurova University:
Anaesthesia Spinal
Ephedrine
Fluid Therapy
Hypotension
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases