Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair.Early Phase 1NCT01939652
Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair
A Early Phase 1 study testing Restrictive VS Standard Fluid Regime and Drag: Crystalloids and Colloids in people with Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair., run by University Clinical Center Tuzla.
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%. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair.
- What is being tested?
- Restrictive VS Standard Fluid Regime and Drag: Crystalloids and Colloids
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jul 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- AAA more than 5,5 cm in diameter tube graft
Who cannot join
- emargency comorbidity maligancy
About this study
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.
Read the detailed description
We investigate effects of a restricted fluid regime versus standard regimen on complications and hospital stay after minilaparatomy aortic aneurysm repair.
- Being tested
- Restrictive VS Standard Fluid Regime, Drag: Crystalloids and Colloids
- Keywords
- minilaparotomy, AAA, fluid regime
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive VS Standard Fluid RegimeProcedure or surgery
Drag: Crystalloids and ColloidsDrug
| Study group | Role | What they receive |
|---|---|---|
| Drag: Crystalloids and Colloids | Active comparator | Drag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour Receives: 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 Receives: Drug: Drag: Crystalloids and Colloids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major and minor complications
Measured: 30 days
Secondary outcomes (3)
ICU and duration of Hospital stay
Measured: 30 days
In-hospital mortality, 30-days mortality
Measured: 30 days
Fluid balance (daily and cumulative)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startFeb 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinical Center Tuzla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939652
- Sponsor's protocol ID
- UKCTUZLA
- Status last verified
- Sep 2013
- First submitted
- 19 Jul 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT01939652
- Acronym / sponsor ID
- UKCTUZLA
- Keywords
- minilaparotomy, AAA, fluid regime
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Clinical Center TuzlaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drag: Crystalloids and Colloids | Active comparator | Procedure: Restrictive VS Standard Fluid RegimeDrag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour |
| Standard fluid regime | Experimental | Drug: Drag: Crystalloids and ColloidsDrag: Crystalloids and Colloids Intraoperative 15 ml/kg/per hour, postoperative 150-200 ml/per hour |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- AAA more than 5,5 cm in diameter tube graft
Key exclusion criteria (1 listed)
- emargency comorbidity maligancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive VS Standard Fluid Regime | Procedure or surgery | Drag: Crystalloids and Colloids |
| Drag: Crystalloids and Colloids | Drug | Standard fluid regime |
Primary outcome
Number of major and minor complications
Time frame: 30 days
3 secondary outcomes
ICU and duration of Hospital stay
Time frame: 30 days
In-hospital mortality, 30-days mortality
Time frame: 30 days
Fluid balance (daily and cumulative)
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Restrictive VS Standard Fluid Regime and Drag: Crystalloids and Colloids in people with Abdominal Aortic Aneurysm > 5.5 cm Effect of a Restricted Intravenous Fluid Regime on Complications and Hospital Stay After the Minilaparotomy AAA Repair., run by University Clinical Center Tuzla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major and minor complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.