Acetazolamide to Prevent Post Operative CSF Leak
Түлхүүр үгс
Хураангуй
Тодорхойлолт
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.
Огноо
| Сүүлд баталгаажуулсан: | 03/31/2020 |
| Эхлээд оруулсан: | 04/27/2016 |
| Тооцоолсон элсэлтийг оруулсан: | 09/08/2016 |
| Эхлээд нийтэлсэн: | 09/14/2016 |
| Сүүлийн шинэчлэлтийг оруулсан: | 04/16/2020 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 04/20/2020 |
| Сургалтын бодит эхлэх огноо: | 08/31/2016 |
| Тооцоолсон анхан шатны ажил дуусах огноо: | 08/31/2021 |
| Судалгааны ажлыг дуусгах өдөр: | 08/31/2021 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: Acetazolamide Arm
Үе шат
Arm Groups
| Гар | Хөндлөнгийн оролцоо / эмчилгээ |
|---|---|
| Other: Acetazolamide Arm Acetazolamide 500 mg twice per day for 5 consecutive days post standard-of-care endoscopic skull base surgery | Drug: Acetazolamide Arm Acetazolamide 500 mg by mouth twice per day for 5 days |
Эрхийн шалгуур
| Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | 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 - Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. Male subjects should refrain from donating semen during treatment and 1 month after stopping treatment. 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) - Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. - It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy - Sulfonamide allergy - Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Incidence of CSF Leakage [30 days]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Incidence of suspected drug adverse events [14 days]
