Efficacy of Preemptive Volume Loading to Prevent Arterial... | NCT01594021

Studies
Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

NCT01594021

Sponsor

Hopital Foch

Status

Terminated

Last Update Posted

Oct 31, 2016Estimated

Enrollment

17Actual

Phase

Phase 4

Conditions

Anesthesia

Interventions

Gelatin 500 mL
Gelatin 50 mL

Countries

France

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

ID	Type	Description	Link
2012-A00368-35	Other Identifier	ANSM

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty of realization of the study

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 5, 2012

First Submission Date that Met QC Criteria

May 5, 2012

First Posted Date

May 8, 2012Estimated

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

Oct 28, 2016

Last Update Posted Date

Oct 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

Detailed Description

This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo elective surgery. The research participants will be randomly assigned to

a control group that will receive a low preemptive volume loading (50 mL of gelatin),
a protocol group that will receive a high preemptive volume loading (500 mL of gelatin).

Volume loading is preceded by the measurement of stroke volume and cardiac output before and after a passive leg elevation test and followed by a standardized anesthetic protocol.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High pre-emptive volume loading	Experimental		Drug: Gelatin 500 mL
Low pre-emptive volume loading	Active Comparator		Drug: Gelatin 50 mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gelatin 500 mL	Drug	intravenous administration	High pre-emptive volume loading

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypotension	mean arterial pressure less than 70% of the baseline measurement	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
hemodynamic effect of leg passive elevation test		30 minutes
hemodynamic effect of volume loading		30 minutes
heart rate monitoring

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing elective surgery.

Exclusion Criteria:

Difficult peripheral venous access
Allergy to gelatin
Symptomatic cardiac disease, rhythm trouble, pace-maker, aortic valvular disease, aortic disease
Morbid obesity, low BMI,
hypovolemia,
Raynaud syndrome or scleroderma,
Contra-indication to propofol, remifentanil or to the use of Bispectral Index,
Hematocrit < 20%.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morgan Le Guen	Hopital Foch	Principal Investigator
Marc Fischler	Hopital Foch	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Foch		Suresnes		92151	France

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
D005780	Gelatin

Ancestor Terms

ID	Term
D012596	Scleroproteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided