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

Primary Purpose

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

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Restrictive VS Standard Fluid Regime
Drag: Crystalloids and Colloids
Sponsored by
University Clinical Center Tuzla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair. focused on measuring minilaparotomy, AAA, fluid regime

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • emargency comorbidity maligancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Drag: Crystalloids and Colloids

    Standard fluid regime

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Number of major and minor complications

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 19, 2013
    Last Updated
    September 5, 2013
    Sponsor
    University Clinical Center Tuzla
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01939652
    Brief Title
    Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair
    Official Title
    Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Clinical Center Tuzla

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair.
    Keywords
    minilaparotomy, AAA, fluid regime

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drag: Crystalloids and Colloids
    Arm Type
    Active Comparator
    Arm Description
    Drag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour
    Arm Title
    Standard fluid regime
    Arm Type
    Experimental
    Arm Description
    Drag: Crystalloids and Colloids Intraoperative 15 ml/kg/per hour, postoperative 150-200 ml/per hour
    Intervention Type
    Procedure
    Intervention Name(s)
    Restrictive VS Standard Fluid Regime
    Intervention Type
    Drug
    Intervention Name(s)
    Drag: Crystalloids and Colloids
    Primary Outcome Measure Information:
    Title
    Number of major and minor complications
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    ICU and duration of Hospital stay
    Time Frame
    30 days
    Title
    In-hospital mortality, 30-days mortality
    Time Frame
    30 days
    Title
    Fluid balance (daily and cumulative)
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: AAA more than 5,5 cm in diameter tube graft Exclusion Criteria: emargency comorbidity maligancy

    12. IPD Sharing Statement

    Learn more about this trial

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

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