Effectiveness of Acetazolamide in Reducing Paralysis of the Leg in Patients Undergoing Aortic Aneurysm Surgery Surgery (AZATAAR)
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).
- 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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised Controlled Trial of the Effectiveness of Acetazolamide in Reducing Cerebrospinal Fluid Pressure for Patients Undergoing Thoracic-abdominal Aortic Repair|
- Intracranial pressure recorded immediately after line insertion, throughout surgery and post-operatively (only recordings post-operatively will be treated as an end-point) [ Time Frame: hourly from start of surgery upto 72 hrs after surgery ] [ Designated as safety issue: No ]reduction in intracranial pressure
- Frequency and volume of CSF drainage [ Time Frame: hourly during and after the operation up to 72 hours ] [ Designated as safety issue: No ]Reduction in frequency and volume of CSF drainage
- Non-clinical paraplegia measured by amplitude of motor evoked potentials [ Time Frame: Measurement of motor evoked potentials measured hourly starting from the time patients are admitted to the critical care unit and the last measurement is when the patient has tracheal extubated ] [ Designated as safety issue: Yes ]The outcome is non-clinical paraplegia measured by amplitude of the motor evoked potentials during postoperative recovery. The signal amplitudes are compared to baseline established during surgery where the postoperative lower limbs amplitude reduction of over 50% and upper limb reduction of less than 50% equates to a risk of paraplegia.
- Clinically evident paraplegia [ Time Frame: Postoperatively assessments will be conducted hourly from the time the patient is awake and able to move until 72 hours after surgery and then once on the day of hospital discharge ] [ Designated as safety issue: Yes ]Postoperatively, clinically evident paraplegia is assessed by the ability of patients to move limbs on awakening. This assessment is performed hourly until 72 hours after admission to the critical care unit and then once on the day of hospital discharge.
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
No Intervention: control group with no acetazolamide
Treatment as usual without acetazolamide treatment
Active Comparator: Acetazolamide
Acetazolamide twice a day, at 12 hour intervals:
Other Name: diamox
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01889498
|Contact: Mark Field, DPhil, MBCHfirstname.lastname@example.org|
|Contact: Fatemeh Jafarzadeh, BSc(Hon)||+441516001616||Fatemeh.Jafarzadeh@lhch.nhs.uk|
|Liverpool heart & chest hospital||Not yet recruiting|
|Liverpool, United Kingdom, L14 3PE|
|Principal Investigator: Mark Field, DPhil, MBCH|
|Liverpool Heart & Chest Hospital||Recruiting|
|Liverpool, United Kingdom, L14 3PE|
|Contact: Mark L Filed, MBBS, PhD email@example.com|
|Contact: Mark L Field, MBBS, PhD firstname.lastname@example.org|
|Principal Investigator:||Mark Field, DPhil, MBBCh||Liverpool Heart & Chest Hospital|