NCT01939652

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2009

Longer than P75 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

4.4 years

First QC Date

July 19, 2013

Last Update Submit

September 5, 2013

Conditions

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

Keywords

minilaparotomyAAAfluid regime

Outcome Measures

Primary Outcomes (1)

  • Number of major and minor complications

    30 days

Secondary Outcomes (3)

  • ICU and duration of Hospital stay

    30 days

  • In-hospital mortality, 30-days mortality

    30 days

  • Fluid balance (daily and cumulative)

    3 days

Study Arms (2)

Drag: Crystalloids and Colloids

ACTIVE COMPARATOR

Drag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour

Procedure: Restrictive VS Standard Fluid Regime

Standard fluid regime

EXPERIMENTAL

Drag: Crystalloids and Colloids Intraoperative 15 ml/kg/per hour, postoperative 150-200 ml/per hour

Drug: Drag: Crystalloids and Colloids

Interventions

Restrictive VS Standard Fluid RegimePROCEDURE
Drag: Crystalloids and Colloids
Drag: Crystalloids and ColloidsDRUG
Standard fluid regime

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • emargency comorbidity maligancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Colloids

Intervention Hierarchy (Ancestors)

Complex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2013

First Posted

September 11, 2013

Study Start

February 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 11, 2013

Record last verified: 2013-09