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

September 5, 2013 updated by: University Clinical Center Tuzla
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • emargency comorbidity maligancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of major and minor complications
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU and duration of Hospital stay
Time Frame: 30 days
30 days
In-hospital mortality, 30-days mortality
Time Frame: 30 days
30 days
Fluid balance (daily and cumulative)
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinical Center Tuzla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKCTUZLA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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