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Acetazolamide to Prevent Post Operative CSF Leak

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ClinicalTrials.gov Identifier: NCT02902133
Recruitment Status : Withdrawn (No participants were identified per inclusion/exclusion criteria)
First Posted : September 15, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ronald Benveniste, University of Miami

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.

Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Leak Drug: Acetazolamide Not Applicable

Detailed Description:

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 effectiveness of Acetazolamide for the prevention of postoperative CSF leak in high-risk patients undergoing transsphenoidal surgery for removal of sellar and parasellar tumors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Acetazolamide
Acetazolamide 500 mg twice per day for 5 days
Drug: Acetazolamide
Acetazolamide 500 mg twice per day for 5 days
Other Name: Diamox




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow CSF leak; such tumors include craniopharyngioma, meningioma, and Rathke cleft cyst.
  • Elective transsphenoidal resection of a pituitary adenoma, with BMI >25, or with observed low or high flow CSF leak during surgery, conferring an elevated risk of postoperative CSF leak.
  • Patients who voluntarily sign Informed Consent

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)
  • Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902133


Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ronald Benveniste, MD, PhD University of Miami

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Responsible Party: Ronald Benveniste, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02902133    
Other Study ID Numbers: 20150742
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ronald Benveniste, University of Miami:
cerebrospinal fluid leak
Additional relevant MeSH terms:
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Cerebrospinal Fluid Leak
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs