Restrictive Versus Standard Fluid Regime in Elective Mini... | NCT01939652

Studies
Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair

NCT01939652

Sponsor

University Clinical Center Tuzla

Status

Completed

Last Update Posted

Sep 11, 2013Estimated

Enrollment

60Actual

Phase

Early Phase 1

Conditions

Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair.

Interventions

Restrictive VS Standard Fluid Regime
Drag: Crystalloids and Colloids

Countries

Not provided

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

Status Module

Record Verification Date

Sep 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

Feb 2009

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 19, 2013

First Submission Date that Met QC Criteria

Sep 5, 2013

First Posted Date

Sep 11, 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

Sep 5, 2013

Last Update Posted Date

Sep 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal and central nervous system, and mortality ranging up to 5%. In our study, we tested the hypothesis that intraoperative and postoperative intravenous restrictive fluid regime reduces postoperative morbidity and mortality and improves the outcome of the treatment of minilaparotomy AAA repair.

Detailed Description

We investigate effects of a restricted fluid regime versus standard regimen on complications and hospital stay after minilaparatomy aortic aneurysm repair.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drag: Crystalloids and Colloids	Active Comparator	Drag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour	Procedure: Restrictive VS Standard Fluid Regime
Standard fluid regime	Experimental	Drag: Crystalloids and Colloids Intraoperative 15 ml/kg/per hour, postoperative 150-200 ml/per hour	Drug: Drag: Crystalloids and Colloids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Restrictive VS Standard Fluid Regime	Procedure		Drag: Crystalloids and Colloids
Drag: Crystalloids and Colloids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of major and minor complications		30 days

Secondary Outcomes

Measure	Description	Time Frame
ICU and duration of Hospital stay		30 days
In-hospital mortality, 30-days mortality		30 days
Fluid balance (daily and cumulative)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AAA more than 5,5 cm in diameter tube graft

Exclusion Criteria:

emargency comorbidity maligancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations