Fluid Coloading and the Incidence of Hypotension

Phase 4

Completed

• Conditions: Complications; Cesarean Section; Anesthesia; Adverse Effect, Spinal and Epidural; Other Fluid Overload
• Interventions: Biological: Cristalloid and colloid coloading

• Registration Number: NCT01741610
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2011-08
• Study Completion: 2012-06
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-12-01
• Study First Posted: 2012-12-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No coloading (Group E)	Cristalloid and colloid coloading	Placebo comparator
Cristalloid (Lactated Ringer) Coloading	Cristalloid and colloid coloading	Cristalloid (Lactated Ringer's) Coloading (Group L)
Colloid (HES) coloading	Cristalloid and colloid coloading	Colloid (HES) coloading (Group C)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hakki Unlugenc; 🇹🇷 Adana, Turkey