Intensive Care UnitEVD-OBSNCT06466811
Prediction of Undesired Obstruction in External Ventricular Drains.
An observational study of Intensive Care Unit and Intraventricular Hemorrhage, run by Nantes University Hospital at 1 site in France.
Trial summary
Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Intraventricular Hemorrhage, External Ventricular Drain
- What is being tested?
- Patients of intensive care unit and Patients of surgical intensive care unit
- How many people
- 640 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jul 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adult patients hospitalized in an intensive care unit and having an EVD.
Who may be able to join
- Patient older than 18 years old,
- admitted to the ICU,
- with first EVD inserted for less than 12 hours,
- and brain imaging (CT or MRI) available in the timespan "24 hours before to 24 hours after" the EVD insertion.
Who cannot join
- EVD intentionally occluded immediately after its insertion,
- purulent cerebrospinal fluid
- Pregnant or breast-feeding patient
- Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment within the 12 hours
- Patient with no health insurance
- Patient under guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Karim LAKHAL, PH
About this study
Official title: Identification of Patients at Risk of Undesired Obstruction in External Ventricular Drain: Development of a Score Based on the Extent of Intra-ventricular Hemorrhage. A Single-Center, Prospective Observational Study.
Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. However, dysfunction of the EVD whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. EVD dysfunction must therefore be promptly detected and treated.
Consequently, identifying high-risk patients and closely monitoring them is imperative. While IVH is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.
- Being tested
- Patients of intensive care unit, Patients of surgical intensive care unit
- Keywords
- Intensive care unit, External ventricular drain, Neuromeningeal infection, Obstruction, Intraventricular hemorrhage, Functional outcome
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients of intensive care unitOther
Patients of intensive care unit having an EVD
Patients of surgical intensive care unitOther
Patients of surgical intensive care unit having an EVD.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the predictive value of IVH severity for EVD obstruction
HIV severity will be estimated using an adaptation of the existing Graeb's score: the Graeb-EVD score. EVD obstruction is defined by an abnormally reduced drainage flow, requiring intervention to restore normal function (cases of EVD malposition will be excluded).The predictive performance of the Graeb-EVD score will be evaluated by the area under the receiver operating characteristic curve (AUC-ROC). The AUC-ROC ranges from 0 to 1. The predictive ability will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.
Measured: From EVD insertion to removal up to 100 days.
Secondary outcomes (9)
To evaluate if HIV is an independent risk factor for the occurrence of at least one episode of unplanned EVD obstruction.
The researcher will study the risk factors for the occurrence of at least one episode of unplanned EVD obstruction (dependent variable in a logistic regression model) by forcing the inclusion of HIV into this model as an explanatory variable. If the 95% confidence interval of the adjusted odds ratio associated with HIV is greater than 1, HIV will be considered an independent risk factor for unplanned EVD obstruction.
Measured: From EVD insertion to removal up to 100 days.
Comparison of the performance of the Graeb-EVD score with that of the original Graeb score and the modified Graeb scores for the prediction of the occurrence of at least one episode of EVD obstruction.
A p-value of <0.05 in the pairwise comparison of areas under the receiver operating characteristics curves will be used to assert the superiority of the performance of one score over another.
Measured: From EVD insertion to removal up to 100 days.
Performance of IVH severity as a predictor of the occurrence of at least one episode of EVD obstruction within the first seven days
HIV severity will be estimated using an adaptation of the existing Graeb's score: the Graeb-EVD score. EVD obstruction is defined by an abnormally reduced drainage flow, requiring intervention to restore normal function (cases of EVD malposition will be excluded). The predictive performance of the Graeb-EVD score will be evaluated by the area under the receiver operating characteristic curve (AUC-ROC). The AUC-ROC ranges from 0 to 1. The predictive ability will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.
Measured: From EVD insertion to day 7.
Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for a new EVD insertion because of obstruction.
The predictive performance of the tested scores will be evaluated by the AUC-ROC. The predictive capacity will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.
Measured: From EVD insertion to hospital discharge up to 12 months.
Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for cerebrospinal fluid internal shunt.
The predictive performance of the tested scores will be evaluated by the AUC-ROC. The predictive capacity will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.
Measured: From EVD insertion to hospital discharge up to 12 months.
To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an unfavorable functional outcome on the day of hospital discharge and at 3±1 months.
Functional outcome will be considered unfavorable if the modified Rankin scale (ranging from 0 to 6) is 2 or higher, and favorable otherwise. The predictive performance of the tested scores will be evaluated by the AUC-ROC. A score will be considered useful if it is associated with an AUC-ROC significantly greater than 0.50.
Measured: From EVD insertion to hospital discharge up to 12 months
To evaluate the effect of unplanned EVD obstruction on the functional outcome assessed on the day of hospital discharge and at 3±1 months.
Functional outcome will be considered unfavorable if the modified Rankin scale is 2 or higher, and favorable otherwise. A multivariate analysis involving risk factors for poor functional outcome (dependent variable) and incorporating the occurrence of at least one episode of unplanned EVD obstruction (explanatory variable) will be conducted. If the 95% confidence interval does not include the value 1, then the variable will be retained as an independent risk factor for the occurrence of the dependent variable. As an explanatory variable, we will test, in separate models, the occurrence of at least one episode of unplanned obstruction and the occurrence of at least two episodes.
Measured: From EVD insertion to month 3 (± 1 month) after IVH.
To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an EVD-related neuromeningeal infection.
Neuromeningeal infection is defined as the administration of antimicrobial therapy for this specific indication for at least 10 days. The predictive performance will be assessed through the area under the receiver operating characteristics curve.
Measured: From EVD insertion to ICU discharge up to 6 months.
To evaluate the effect of unplanned EVD obstruction on the need for internalization of the ventricular shunt (ventriculoperitoneal or ventriculoatrial shunt).
A multivariate analysis involving risk factors for the need for internalization of the ventricular shunt (dependent variable) and incorporating the occurrence of at least one episode of unplanned EVD obstruction (explanatory variable) will be conducted. If the 95% confidence interval does not include the value 1, then the variable will be retained as an independent risk factor for the occurrence of the dependent variable.
Measured: From EVD insertion to ICU discharge up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start4 Jul 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466811
- Sponsor's protocol ID
- RC24_0074
- Acronym
- EVD-OBS
- Status last verified
- Jul 2024
- First submitted
- 14 May 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Patients at Risk of Undesired Obstruction in External Ventricular Drain: Development of a Score Based on the Extent of Intra-ventricular Hemorrhage. A Single-Center, Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06466811
- Acronym / sponsor ID
- EVD-OBS / RC24_0074
- Keywords
- Intensive care unit, External ventricular drain, Neuromeningeal infection, Obstruction, Intraventricular hemorrhage, Functional outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jun 2024 (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.
Acute obstructive hydrocephalus often complicates intraventricular hemorrhage (IVH). The insertion of an external ventricular drain (EVD) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. However, dysfunction of the EVD whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. EVD dysfunction must therefore be promptly detected and treated.
Consequently, identifying high-risk patients and closely monitoring them is imperative. While IVH is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized in an intensive care unit and having an EVD.
Key inclusion criteria (4 listed)
- Patient older than 18 years old,
- admitted to the ICU,
- with first EVD inserted for less than 12 hours,
- and brain imaging (CT or MRI) available in the timespan "24 hours before to 24 hours after" the EVD insertion.
Key exclusion criteria (6 listed)
- EVD intentionally occluded immediately after its insertion,
- purulent cerebrospinal fluid
- Pregnant or breast-feeding patient
- Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment within the 12 hours
- Patient with no health insurance
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 |
|---|---|---|
| Patients of intensive care unitPatients of intensive care unit having an EVD | Other | – |
| Patients of surgical intensive care unitPatients of surgical intensive care unit having an EVD. | Other | – |
Primary outcome
Assessment of the predictive value of IVH severity for EVD obstruction
Time frame: From EVD insertion to removal up to 100 days.
HIV severity will be estimated using an adaptation of the existing Graeb's score: the Graeb-EVD score. EVD obstruction is defined by an abnormally reduced drainage flow, requiring intervention to restore normal function (cases of EVD malposition will be excluded).The predictive performance of the Graeb-EVD score will be evaluated by the area under the receiver operating characteristic curve (AUC-ROC). The AUC-ROC ranges from 0 to 1. The predictive ability will be considered acceptable if associated with an AUC-ROC greater than 0.70, good if greater than 0.80, and excellent if greater than 0.90.
9 secondary outcomes
To evaluate if HIV is an independent risk factor for the occurrence of at least one episode of unplanned EVD obstruction.
Time frame: From EVD insertion to removal up to 100 days.
Comparison of the performance of the Graeb-EVD score with that of the original Graeb score and the modified Graeb scores for the prediction of the occurrence of at least one episode of EVD obstruction.
Time frame: From EVD insertion to removal up to 100 days.
Performance of IVH severity as a predictor of the occurrence of at least one episode of EVD obstruction within the first seven days
Time frame: From EVD insertion to day 7.
Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for a new EVD insertion because of obstruction.
Time frame: From EVD insertion to hospital discharge up to 12 months.
Evaluation of the 3 Graeb scores (original, modified and EVD) as predictors of the need for cerebrospinal fluid internal shunt.
Time frame: From EVD insertion to hospital discharge up to 12 months.
To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an unfavorable functional outcome on the day of hospital discharge and at 3±1 months.
Time frame: From EVD insertion to hospital discharge up to 12 months
To evaluate the effect of unplanned EVD obstruction on the functional outcome assessed on the day of hospital discharge and at 3±1 months.
Time frame: From EVD insertion to month 3 (± 1 month) after IVH.
To evaluate whether the Graeb-EVD, original Graeb, and modified Graeb scores are useful in predicting an EVD-related neuromeningeal infection.
Time frame: From EVD insertion to ICU discharge up to 6 months.
To evaluate the effect of unplanned EVD obstruction on the need for internalization of the ventricular shunt (ventriculoperitoneal or ventriculoatrial shunt).
Time frame: From EVD insertion to ICU discharge up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Intraventricular Hemorrhage, run by Nantes University Hospital at 1 site in France.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Jul 2024. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim LAKHAL, PH (33 2 53 48 27 85, karim.lakhal@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the predictive value of IVH severity for EVD obstruction (time frame: From EVD insertion to removal up to 100 days.). 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 12 Jul 2024.