Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage

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Brief Title

Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage

Official Title

Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage

Brief Summary

      Acute hydrocephalus is a common complication following subarachnoid hemorrhage (SAH). Early
      and emergency insertion of external ventricular drain (EVD) is standard treatment of acute
      post-SAH hydrocephalus. According to the high risk of infection associated with EVD, the
      study evaluates the outcome of early EVD conversion to ventriculoperitoneal shunt (VPS) in
      poor-grade SAH patients.
    

Detailed Description

      This study was performed on patients diagnosed with high grade SAH (WFNS 4-5) who undergo EVD
      within 24 hours of their admission. The conversion of EVD to VPS is performed within 7-10
      days of EVD insertion, defined as early VPS group. The ventricular catheter is inserted in
      lateral ventricle using the same burr hole of EVD or the contralateral Kocher's point. All
      ruptured aneurysms could be closed by endovascular techniques or surgery.

      The goal is to discontinuing EVD or its conversion to VPS within 7 to 10 days of insertion.
      At day 5-7 of EVD insertion, the EVD level is elevated from 15 cmH2O to 25 centimeter of
      water (cmH2O) gradually. The patients is evaluated during the 48 hours for cerebrospinal
      fluid (CSF) volume discharge, neurological consciousness, and hydrocephalus within brain CT
      scan acquired at the end of 48 hours of observation. If the daily CSF fluid discharge will be
      greater than 100 ml, brain CT scan shows evidence of HCP, there is any CSF leak from around
      the catheter, or the patient experiences GCS drop for 2 points or more, EVD is converted to
      VPS.

      EVD conversion to VPS is postponed if there is any evidence of CSF infection within the last
      CSF analysis obtained 48 hours before VPS placement, patient experiences fever (>38.5° C)
      without any other source, or there is any evidence of severe vasospasm in transcranial
      Doppler (TCD) imaging or brain CT angiography. Otherwise, The EVD is discontinued.

      For all patients, a brain CT scan is taken to evaluate the location of shunt 24 hours after
      VPS placement. Forty-eight hours after VPS placement, lumbar puncture (LP) is performed to
      collect CSF for ruling out the possibility of shunt infection or ventriculitis. Shunt
      malfunction (approved by imaging or signs of HCP) is reported if it occurred within 3 months
      of VPS placement.

      When VPS malfunction is diagnosed it is revised. CSF infection is considered if there is a
      positive culture or ratio of CSF white blood cell count (WBC)/ red blood cell count (RBC) to
      blood WBC/RBC was more than 3. All patients is evaluated for clinical condition using
      modified Rankin scale (mRs) at discharge and 6 months later.
    


Study Type

Interventional


Primary Outcome

rate of ventriculo-peritoneal malfunction

Secondary Outcome

 RBC / protein level in CSF association with VPS malfunction

Condition

Subarachnoid Hemorrhage

Intervention

External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)

Study Arms / Comparison Groups

 Early VPS
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

January 2017

Completion Date

March 2021

Primary Completion Date

February 2021

Eligibility Criteria

        Inclusion Criteria:

          -  patients with SAH and World Federation of Neurosurgeon (WFNS) Grade 4 or 5 and

          -  patient who underwent ventriculostomy (EVD insertion) within 24 hours of SAH onset.

        Exclusion Criteria:

          -  patients with Glasgow Coma Scale of (GCS) 3 and fixed non-reactive pupils,

          -  patients in whom EVD was inserted in the other hospital,

          -  patients were successfully weaned from EVD with 7-10 days of EVD insertion

          -  patients who died during hospitalization.
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Iran, Islamic Republic of

Location Countries

Iran, Islamic Republic of

Administrative Informations


NCT ID

NCT04567277

Organization ID

T5097


Responsible Party

Principal Investigator

Study Sponsor

Mashhad University of Medical Sciences


Study Sponsor

, , 


Verification Date

March 2022