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

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)

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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