The Effect of Intravenous Prehydration on the Hemodynamic... | NCT01835873

Studies
The Effect of Intravenous Prehydration on the Hemodynamic Status of Healthy Parturients Undergoing Spinal Anesthesia for Cesarean Delivery

NCT01835873

Sponsor

Paraskevi Matsota

Status

Completed

Last Update Posted

Jul 15, 2013Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Hypotension

Interventions

Lactated Ringer's
HES 130/0.42

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Comparative Study of the Effect of 6% Hydroxyethyl Starch 130/0.42 vs Lactated Ringer's Preload on the Hemodynamic Status of Parturients Undergoing Spinal Anesthesia for Elective Cesarean Delivery. Arterial Pulse Contour Analysis (FloTrac/VigileoTM) is Employed for Continuous Monitoring of Maternal Hemodynamic Parameters

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Not provided

First Submitted Date

Apr 6, 2013

First Submission Date that Met QC Criteria

Apr 11, 2013

First Posted Date

Apr 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2013

Last Update Posted Date

Jul 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paraskevi Matsota, Assistant Professor of Anesthesiology, MD, PhD, Attikon HospitalSponsor-Investigator

Lead Sponsor

Paraskevi MatsotaOTHER

Collaborators

Not provided

Description Module

Brief Summary

Regional anesthesia (spinal, epidural) is considered the method of choice for anesthesia obstetric deliveries because of the ability to use fewer drugs, a more direct experience of childbirth and the capability to provide excellent postoperative analgesia. However, the incidence of hypotension after spinal anesthesia for cesarean delivery is high and can lead to maternal and fetal morbidities. Certain interventions may reduce the incidence and severity of spinal anesthesia induced hypotension, including the use of vasopressors and intravenous pre- or co-hydration using different types of volume expanders; crystalloid or colloid solutions. Such interventions aim to increase maternal cardiac output, which is the key in attenuating the hypotensive response to spinal anesthesia.

The primary purpose of this study is to compare the efficacy of intravenous prehydration (preloading) of healthy parturients scheduled for caesarean section with either a crystalloid (Ringer's lactated) or colloid solution (HES 130/0.42) in the prevention of hypotension after spinal anesthesia.

The FloTrac/VigileoTM device provides continuous monitoring of maternal cardiac output by employment of a minimally invasive technique based on arterial pulse contour analysis. Assessment of maternal hemodynamic status using the FloTrac/VigileoTM constitutes a secondary outcome. Other secondary outcomes are total amount of vasopressors used, neonatal outcome, intraoperative side effects and maternal satisfaction scores.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactated Ringer's	Active Comparator	Crystalloid solution - 1000 ml preload	Other: Lactated Ringer's
HES 130/0.42	Active Comparator	Hydroxyethyl starch (HES 130/0.42) - 500 ml preload	Other: HES 130/0.42

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactated Ringer's	Other		Lactated Ringer's
HES 130/0.42

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of spinal anesthesia induced hypotension in elective cesarean deliveries preloaded with either crystalloid or colloid solution.		Maternal hemodynamic data is assessed before volume preload, immediately after volume preload, immediately after spinal anesthesia and at one minute intervals thereafter until placental delivery. Expected average of 40 minutes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) I and II parturients
singleton gestation
term gestation (gestational period more than 37 weeks)

Exclusion Criteria:

extremes of weight (<50 Kgr or >120 Kgr)
extremes of height (<150 cm or >180 cm)
baseline heart rate less than 65 bpm
active labor
known fetal abnormalities
placental abruption, placenta previa/accreta
pregnancy induced hypertension
anemia (hemoglobin < 9 gr/dl)
cardiac, respiratory or renal disease
diabetes mellitus
spinal cord abnormalities
previous spinal surgery
preexisting neurological dysfunction
known allergy to any protocol medication
any absolute contraindication to regional anesthesia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Department of Anesthesiology, Attikon University Hospital		Athens	Attica	12462	Greece

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077325	Ringer's Lactate
C523275	HES 130-0.42-6:1

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided