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

NCT ID: NCT01939652

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-07-31

Brief Summary

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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

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

Conditions

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

Keywords

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minilaparotomy AAA fluid regime

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drag: Crystalloids and Colloids

Drag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour

Group Type ACTIVE_COMPARATOR

Restrictive VS Standard Fluid Regime

Intervention Type PROCEDURE

Standard fluid regime

Drag: Crystalloids and Colloids Intraoperative 15 ml/kg/per hour, postoperative 150-200 ml/per hour

Group Type EXPERIMENTAL

Drag: Crystalloids and Colloids

Intervention Type DRUG

Interventions

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Restrictive VS Standard Fluid Regime

Intervention Type PROCEDURE

Drag: Crystalloids and Colloids

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* AAA more than 5,5 cm in diameter tube graft

Exclusion Criteria

* emargency comorbidity maligancy
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Clinical Center Tuzla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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UKCTUZLA

Identifier Type: -

Identifier Source: org_study_id