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Prevention of chronic overdrainage complications via stepwise up-titration of valve pressure after pediatric ventriculoperitoneal shunting: study protocol for a randomized controlled trial

Prevention of chronic overdrainage complications via stepwise up-titration of valve pressure after pediatric ventriculoperitoneal shunting: study protocol for a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108353
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-09-15
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Pediatric hydrocephalus

Interventions

Control Group:Maintain the shunt valve pressure
Experiment Group:increase the shunt valve pressure by one level.

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.Age = 3 months; 4.Stable ventricular size for >= 3 months, defined as a change in Evans index 3 months apart prior to enrollment; 5.Availability of complete medical records, with enrollment occurring within 36 months after the shunt surgery; 6.Willingness of the participant and their guardian(s) to cooperate with the study, with the ability to understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Presence of chronic overdrainage complications at the time of enrollment; 2.Prior adjustment of the shunt valve pressure for any reason; 3.Inability to accurately adjust the shunt valve pressure or confirm the pressure setting due to mechanical failure, imaging artifact, or other reasons; 4.Imaging evidence of progressive intracranial space-occupying lesions, or severe brain parenchymal damage precluding accurate neurological assessment; 5.Clinical or imaging evidence suggesting shunt obstruction, disconnection, or definite absence of cerebrospinal fluid flow requiring shunt revision; 6.Conversion to external ventricular drainage due to infection or other causes after ventriculoperitoneal shunting; 7.Previous or concurrent cerebrospinal fluid diversion surgery other than ventriculoperitoneal shunting (excluding Ommaya reservoir).

Design outcomes

Primary

MeasureTime frame
The incidence rate of complications from excessive shunt;

Secondary

MeasureTime frame
Neural development growth rate;The incidence rate of shunt failure;

Countries

China

Contacts

Public ContactZhang Wangming

Zhujiang Hospital of Southern Medical University

wzhang@vip.126.com+86 20 6164 3064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026