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Effectiveness of Acetazolamide in Reducing Paralysis of the Leg in Patients Undergoing Aortic Aneurysm Surgery Surgery

NCT01889498 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-12-31

No results posted yet for this study

Summary

The aorta is a large vessel that carries blood away from the heart. Sometimes it becomes dilated (swells) and this is known as 'aneurysm'. It may cause either dissection (splitting of the wall) or rupture (bursting).

Treatments could be through open surgery or by use of stents (tubular mesh) through the groin. There is a risk of causing paraplegia, which is the loss/weakness of leg function as well as incontinence (loss of bladder and/or bowel control).

To try and prevent this, a number of techniques are used such as removing/draining of cerebrospinal fluid (CSF) (the clear fluid surrounding the brain and spinal cord).

Sometimes however;

* CSF cannot be drained
* drain cannot be inserted
* draining is unlikely to improve the situation
* Paralysis/weakness of the leg is seen

In these situations, the use of a drug called acetazolamide may be helpful. This reduces the production of CSF and therefore decreases the need for CSF draining. It may also have an effect in decreasing the risk of paraplegia.

Patients will be randomly (by chance) placed into one of two groups. One will get the drug as tablets and injection and the other will not receive any acetazolamide at all. Blood tests will be done in both groups. We expect to have 100 patients in the study, with patient involvement for a total of 10 days (maximum).

Conditions

  • Thoracic Aneurysm

Interventions

DRUG

Acetazolamide

Acetazolamide twice a day, at 12 hour intervals: * 250 mg Tablets; one tablet to be taken twice daily from three days before the day of surgery * One tablet to take two hours before surgery * 500mg Intravenous Acetazolamide; to be administered upon arrival in critical care post-surgery; continuing at 12 hour intervals until last acetazolamide administration at 72 hours.

Sponsors & Collaborators

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Mark Field, DPhil, MBBCh · Liverpool Heart & Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889498 on ClinicalTrials.gov