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

NCT01889498 | Unknown Phase 4

• 2 other identifiers: 9542013-001447-31
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Acetazolamide, intracranial/cerebrospinal fluid pressure, paraplegia, thoracoabdominal aortic surgery

Outcome Measures

Primary Outcomes (1)

• Intracranial pressure recorded immediately after line insertion, throughout surgery and post-operatively (only recordings post-operatively will be treated as an end-point)

  reduction in intracranial pressure

  hourly from start of surgery upto 72 hrs after surgery

Secondary Outcomes (1)

• Frequency and volume of CSF drainage

  hourly during and after the operation up to 72 hours

Other Outcomes (2)

• Non-clinical paraplegia measured by amplitude of motor evoked potentials

  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

• Clinically evident paraplegia

  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

Study Arms (2)

control group with no acetazolamide

NO INTERVENTION

Treatment as usual without acetazolamide treatment

Acetazolamide

ACTIVE COMPARATOR

Treatment arm

Drug: Acetazolamide

Interventions

Acetazolamide DRUG

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.

Also known as: diamox

Acetazolamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead

Study Sites (2)

Liverpool heart & chest hospital

Liverpool, L14 3PE, United Kingdom

NOT YET RECRUITING

Liverpool Heart & Chest Hospital

Liverpool, L14 3PE, United Kingdom

RECRUITING

Related Publications (1)

• Crawford ES, Crawford JL, Safi HJ, Coselli JS, Hess KR, Brooks B, Norton HJ, Glaeser DH. Thoracoabdominal aortic aneurysms: preoperative and intraoperative factors determining immediate and long-term results of operations in 605 patients. J Vasc Surg. 1986 Mar;3(3):389-404. doi: 10.1067/mva.1986.avs0030389.

  PMID: 3951025 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Paraplegia

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark Field, DPhil, MBBCh

  Liverpool Heart & Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Field, DPhil, MBCH

CONTACT

+441516001616; mark.field@lhch.nhs.uk

Fatemeh Jafarzadeh, BSc(Hon)

CONTACT

+441516001616; Fatemeh.Jafarzadeh@lhch.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant cardiac surgeon

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 28, 2013
• Study Start: July 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

GB (2)