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

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ClinicalTrials.gov Identifier: NCT01939652
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
University Clinical Center Tuzla

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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair. Procedure: Restrictive VS Standard Fluid Regime Drug: Drag: Crystalloids and Colloids Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair
Study Start Date : February 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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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



Primary Outcome Measures :
  1. Number of major and minor complications [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. ICU and duration of Hospital stay [ Time Frame: 30 days ]
  2. In-hospital mortality, 30-days mortality [ Time Frame: 30 days ]
  3. Fluid balance (daily and cumulative) [ Time Frame: 3 days ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • emargency comorbidity maligancy

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Responsible Party: University Clinical Center Tuzla
ClinicalTrials.gov Identifier: NCT01939652     History of Changes
Other Study ID Numbers: UKCTUZLA
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by University Clinical Center Tuzla:
minilaparotomy
AAA
fluid regime

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases