Cerebrospinal Fluid LeakPhase 4NCT07876713
Acetazolamide to Reduce Spinal Fluid Leaks After Spine Surgery.
A Phase 4 study testing Acetazolamide in people with Cerebrospinal Fluid Leak and Dural Tear, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness and safety of acetazolamide in helping patients recover from accidental dural tears during spine surgery. Adding acetazolamide to standard post-surgery care is hypothesized to be a safe and effective way to reduce spinal fluid leakage, ease headaches, and speed up recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrospinal Fluid Leak, Dural Tear, Incidental Durotomy
- What is being tested?
- Acetazolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Apr 2025to 1 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Patients who sustained an incidental/iatrogenic dural tear during degenerative lumbar spine surgery.
- Eligible to receive oral acetazolamide safely without contraindications.
Who cannot join
- Known hypersensitivity or allergic reaction to acetazolamide or other sulfonamide derivatives.
- Significant renal impairment (creatinine clearance < 50 mL/min) or severe hepatic disease.
- Significant pre-existing cardiovascular conditions.
- Pregnant or breastfeeding females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Acetazolamide Medication to Reduce Spinal Fluid Leaks and Speed Up Recovery After Spine Surgery
This study aims to evaluate the effectiveness and safety of acetazolamide in helping patients recover from accidental dural tears during spine surgery. Adding acetazolamide to standard post-surgery care is hypothesized to be a safe and effective way to reduce spinal fluid leakage, ease headaches, and speed up recovery.
Read the detailed description
Researchers conducted a randomized controlled trial with 26 patients who experienced a dural tear during spine surgery at Ain Shams University Hospitals. The patients were divided into two equal groups of 13: The Interventional Group received 250 mg of acetazolamide three times daily for 2 weeks alongside standard care, while the Control Group received standard care without acetazolamide. The team measured the amount of spinal fluid draining from patients, how long it took for wounds to close, headache severity, and any side effects over the postoperative period.
- Conditions
- Cerebrospinal Fluid Leak, Dural Tear, Incidental Durotomy
- Being tested
- Acetazolamide, Standard Care (in control arm)
- Keywords
- Acetazolamide, Spine Surgery, Lumbar Drain
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
250 mg three times daily for 2 weeks
Standard Care (in control arm)Other
Standard postoperative care without acetazolamide
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Received 250 mg of acetazolamide three times daily for 2 weeks alongside standard care. Receives: Drug: Acetazolamide |
| Control Group | Active comparator | Received standard care without acetazolamide Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Drain Output
Daily volume of cerebrospinal fluid (CSF) drainage measured in milliliters (mL) collected via the non-suction lumbar drain.
Measured: Daily on postoperative days 1, 2, 3, and 4
Time to Complete Wound Closure
Number of days from surgery until complete wound epithelialization and cessation of any fluid leakage.
Measured: Up to 20 days postoperatively
Secondary outcomes (2)
Orthostatic Headache Score
Severity of positional headache calculated as the difference between recumbent and standing positions using the Visual Analogue Scale (VAS, range 0-100 mm; higher scores indicate greater pain severity).
Measured: Postoperative day 3
Incidence of Postoperative Complications
Number of participants experiencing adverse events including pseudo meningocele formation, postoperative meningitis, or drug-related hypokalemia.
Measured: Postoperative day 14 (end of treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start6 Apr 2025
- Primary completion26 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid LeakStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zakaria Hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876713
- Sponsor's protocol ID
- Acetazolamide-ASU-2025-01
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Acetazolamide Medication to Reduce Spinal Fluid Leaks and Speed Up Recovery After Spine Surgery
- ClinicalTrials.gov ID
- NCT07876713
- Acronym / sponsor ID
- Acetazolamide-ASU-2025-01
- Conditions
- Cerebrospinal Fluid Leak, Dural Tear, Incidental Durotomy
- Keywords
- Acetazolamide, Spine Surgery, Lumbar Drain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 26 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness and safety of acetazolamide in helping patients recover from accidental dural tears during spine surgery. Adding acetazolamide to standard post-surgery care is hypothesized to be a safe and effective way to reduce spinal fluid leakage, ease headaches, and speed up recovery.
Detailed description
Researchers conducted a randomized controlled trial with 26 patients who experienced a dural tear during spine surgery at Ain Shams University Hospitals. The patients were divided into two equal groups of 13: The Interventional Group received 250 mg of acetazolamide three times daily for 2 weeks alongside standard care, while the Control Group received standard care without acetazolamide. The team measured the amount of spinal fluid draining from patients, how long it took for wounds to close, headache severity, and any side effects over the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Drug: AcetazolamideReceived 250 mg of acetazolamide three times daily for 2 weeks alongside standard care. |
| Control Group | Active comparator | Other: Standard Care (in control arm)Received standard care without acetazolamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and older.
- Patients who sustained an incidental/iatrogenic dural tear during degenerative lumbar spine surgery.
- Eligible to receive oral acetazolamide safely without contraindications.
Key exclusion criteria (4 listed)
- Known hypersensitivity or allergic reaction to acetazolamide or other sulfonamide derivatives.
- Significant renal impairment (creatinine clearance < 50 mL/min) or severe hepatic disease.
- Significant pre-existing cardiovascular conditions.
- Pregnant or breastfeeding females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetazolamide250 mg three times daily for 2 weeks | Drug | Interventional Group |
| Standard Care (in control arm)Standard postoperative care without acetazolamide | Other | Control Group |
Primary outcome
Lumbar Drain Output
Time frame: Daily on postoperative days 1, 2, 3, and 4
Daily volume of cerebrospinal fluid (CSF) drainage measured in milliliters (mL) collected via the non-suction lumbar drain.
Time to Complete Wound Closure
Time frame: Up to 20 days postoperatively
Number of days from surgery until complete wound epithelialization and cessation of any fluid leakage.
2 secondary outcomes
Orthostatic Headache Score
Time frame: Postoperative day 3
Incidence of Postoperative Complications
Time frame: Postoperative day 14 (end of treatment period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetazolamide in people with Cerebrospinal Fluid Leak and Dural Tear, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Drain Output (time frame: Daily on postoperative days 1, 2, 3, and 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.