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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939652
• Other study ID #: UKCTUZLA
• Status: Completed
• Phase: Phase 0
• First received: July 19, 2013
• Last updated: September 5, 2013
• Start date: February 2009
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: University Clinical Center Tuzla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia: Federal Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• emargency comorbidity maligancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Restrictive VS Standard Fluid Regime

Drug:
• Drag: Crystalloids and Colloids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Clinical Center Tuzla

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major and minor complications		30 days	Yes
Secondary	ICU and duration of Hospital stay		30 days	Yes
Secondary	In-hospital mortality, 30-days mortality		30 days	Yes
Secondary	Fluid balance (daily and cumulative)		3 days	Yes