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

U

University Clinical Center Tuzla

Status and phase

Completed
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.

Treatments

Drug: Drag: Crystalloids and Colloids
Procedure: Restrictive VS Standard Fluid Regime

Study type

Interventional

Funder types

Other

Identifiers

NCT01939652
UKCTUZLA

Details and patient eligibility

About

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.

Full description

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

Enrollment

60 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • emargency comorbidity maligancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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