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

• Sponsor: University Clinical Center Tuzla (Other)
• Overall Status: Completed
• CT.gov ID: NCT01939652
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 52.9

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Feb 1, 2009
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of major and minor complications [30 days]

Secondary Outcome Measures

1. ICU and duration of Hospital stay [30 days]

2. In-hospital mortality, 30-days mortality [30 days]

3. Fluid balance (daily and cumulative) [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• emargency comorbidity maligancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Clinical Center Tuzla

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Clinical Center Tuzla
• ClinicalTrials.gov Identifier: NCT01939652
• Other Study ID Numbers: UKCTUZLA
• First Posted: Sep 11, 2013
• Last Update Posted: Sep 11, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by University Clinical Center Tuzla: minilaparotomy; AAA; fluid regime
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal

Study Results

No Results Posted as of Sep 11, 2013