Clinical Trial: Acetazolamide to Prevent Post Operative CSF Leak

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery

Brief Summary: This is a non-randomized pilot study of Acetazolamide administration in patients at high risk for CSF leak after endoscopic skull base surgery.

Detailed Summary:

Transsphenoidal resection of sellar and parasellar tumors is associated with a significant risk of intraoperative cerebrospinal fluid (CSF) leak (up to 25% for pituitary adenomas, and nearly 100% for craniopharyngiomas and other complex tumors). Postoperative CSF leaks are dangerous complications that can result in infectious meningitis. In patients with intraoperative CSF leaks, various types of intraoperative repair can minimize the risk of postoperative CSF leak to a range of 8-10% (Gaynor et al., 2013). The risk of postoperative CSF leak is further increased by high flow CSF leak and by patient factors, in particular obesity (Dlouhy et al., 2012). The risk of postoperative leak can be decreased further by prophylactic placement of an invasive lumbar spinal drain after surgery (Patel et al., 2013), but lumbar drains are associated with various disadvantages including discomfort, prolonged hospital stay, and risk of infection, bleeding and other serious complications. Less risky strategies for minimizing the risk of postoperative CSF leak in this patient population are needed.

Acetazolamide (Diamox) is a carbonic anhydrase inhibitor that decreases production of CSF by reducing sodium transport across the choroid plexus epithelium in the ventricles of the brain. Acetazolamide can be given orally or by IV, and is widely used clinically for decreasing CSF production in patients with idiopathic intracranial hypertension (pseudotumor cerebri) and active CSF leak after surgery or head trauma. In one small pilot study, Acetazolamide was used successfully in lieu of lumbar spinal drainage in patients undergoing elective thoracic aortic aneurysm repair. Acetazolamide has a well- established safety profile and rapid onset of action (4 hours when given IV, 12 hours when given orally). We plan a prospective pilot study of Diamox intended to assess the safety and possible effectiven
Sponsor: University of Miami

Current Primary Outcome: No CSF Leakage [ Time Frame: 30 days ]

Occurrence of postoperative cerebrospinal fluid leak will be assessed based on clinical findings (for example, drainage of clear fluid from nose)


Original Primary Outcome: Same as current

Current Secondary Outcome: Complications from medication administration [ Time Frame: 30 days ]

Recognized complications of acetazolomide administration (such as paresthesias in the hands or feet, or electrolyte abnormalities) will be assessed at the time of clinic visits.


Original Secondary Outcome: Same as current

Information By: University of Miami

Dates:
Date Received: April 28, 2016
Date Started: September 2016
Date Completion: September 2017
Last Updated: April 19, 2017
Last Verified: April 2017