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A retrospective study of the effect of continuous epidural infusion of hydroxyethyl starch on the response rate in the treatment of spontaneous intracranial hypotension syndrome

A retrospective study of the effect of continuous epidural infusion of hydroxyethyl starch on the response rate in the treatment of spontaneous intracranial hypotension syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104607
Enrollment
Unknown
Registered
2025-06-19
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spontaneous intracranial hypotension syndrome

Interventions

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for spontaneous intracranial hypotension syndrome according to the International Classification of Headache Disorders, 3rd edition (ICHD-3); 2. Received continuous epidural injection of HES therapy at Zhongshan Hospital Affiliated to Fudan University from January 2020 to December 2024; 3. Complete follow-up data: Have complete clinical medical records, imaging examination data and at least 3 months of follow-up records; 4. Voluntary participation: Patients or their families give informed consent to the study.

Exclusion criteria

Exclusion criteria: 1.Concomitant neurological disorders??: Intracranial space-occupying lesions, cerebrovascular diseases, intracranial infections, etc; 2.Severe systemic diseases??: Severe cardiac, hepatic, or renal dysfunction, coagulation disorders, etc., which may affect treatment efficacy or safety assessment; 3.??Prior cranial/spinal surgery??: History of craniotomy or spinal surgery that may interfere with spontaneous intracranial hypotension (SIH) diagnosis or treatment evaluation; 4.Non-standard treatment: such as conservative treatment not lasting enough time (at least 2 weeks) or EBP/HES treatment Not operating as standard; 5.Insufficient follow-up??: Follow-up duration <3 months, precluding long-term efficacy evaluation; 6.Other types of intracranial hypotension??: Traumatic or iatrogenic intracranial hypotension.

Design outcomes

Primary

MeasureTime frame
Treatment success rate (complete symptom relief and/or improvement in imaging evidence);

Secondary

MeasureTime frame
Headache severity (VAS score);Symptom relief time (headache relief time, disappearance time of accompanying symptoms);Recurrence rate (symptom recurrence during follow-up period);Infection after EBP surgery;

Countries

China

Contacts

Public ContactMiao Changhong

Zhongshan Hospital, Fudan University

miaochh@163.com+86 180 1731 7624

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026