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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Dr Mark Field, Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01889498
First received: June 4, 2013
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Thoracic Aneurysm
Drug: Acetazolamide
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group with no acetazolamide
Treatment as usual without acetazolamide treatment
Active Comparator: Acetazolamide
Treatment arm
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.
Other Name: diamox

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have given consent and are 18+ years old
  • Patients who have been able to comply with the pre-operative course of acetazolamide treatment (treatment group) and who have had blood sample collected three days prior to surgery
  • Patients with inserted spinal drain

Exclusion Criteria:

  • Non-elective patients, who were not able to participate in pre-operative acetazolamide treatment and blood sample tests three days prior to surgery
  • Patients without consent
  • Patients in whom a spinal drain could not be positioned
  • Patients with blood stained CSF
  • Patients who have not adhered to pre-operative course of acetazolamide treatment
  • Patients who have had a reaction to the drug, and consequently have had acetazolamide discontinued (but will make note of specific reactions and number of patients involved)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889498

Contacts
Contact: Mark Field, DPhil, MBCH +441516001616 mark.field@lhch.nhs.uk
Contact: Fatemeh Jafarzadeh, BSc(Hon) +441516001616 Fatemeh.Jafarzadeh@lhch.nhs.uk

Locations
United Kingdom
Liverpool heart & chest hospital Not yet recruiting
Liverpool, United Kingdom, L14 3PE
Principal Investigator: Mark Field, DPhil, MBCH         
Sponsors and Collaborators
Liverpool Heart and Chest Hospital NHS Foundation Trust
Investigators
Principal Investigator: Mark Field, DPhil, MBBCh Liverpool Heart & Chest Hospital
  More Information

Publications:
Responsible Party: Dr Mark Field, Consultant cardiac surgeon, Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01889498     History of Changes
Other Study ID Numbers: 954, 2013-001447-31
Study First Received: June 4, 2013
Last Updated: June 26, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:
Acetazolamide, intracranial/cerebrospinal fluid pressure, paraplegia, thoracoabdominal aortic surgery

Additional relevant MeSH terms:
Aortic Aneurysm, Thoracic
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014