Clinical trial NCT01801813: Risk Factors of Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery (Cranioscore).
Official title: Observational Study of Risk Factors of Neuro-critical Care Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery : a Prospective Validation of the Cranioscore.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuro-surgery
Brain Tumor
Post-operative Complications
Neuro-ICU Stay
Keywords: Neuro-surgery
Post-operative complications
Neuro-ICU resources
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 795
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing neuro-surgery for a brain tumor

Brief summary: Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. There are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (Neuro-ICU, ICU,surgical ward).

Determining risk factors of post-operative complications could optimise resources. Therefore hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.

Detailed description: Retrospective analysis of a prospective database to create a Risk Score. Post-operative neurosurgery complications recording (Hyponatremia \< 135mmol/l,Insulin administration, Nausea-Vomiting, Glasgow Coma Score, Inhalation, Post-operative intra-cranial bleeding requiring neurosurgery, Intra-cranial hypertension, Use of osmotherapy, Status epilepticus, Brain death, Death).

Collection of datas as Duration of mechanical ventilation, Length of ICU stay, Length of hospital stay.

Validation of this score on an independent prospective cohort.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria:

* Neuro-surgical emergency

Primary outcomes:
measure: Post-operative complications requiring Neuro-ICU stay ≥ 24 hours after surgery for neurosurgical reason.
timeFrame: During ICU stay, average of 24 hours
Secondary outcomes:
measure: Describing post-operative complications in patients undergoing neuro-surgery for brain tumor.
timeFrame: During ICU stay, average of 24 hours
measure: Duration of mechanical ventilation
timeFrame: Duration of mechinal ventilation, average of 12 hours
measure: Length of ICU stay
timeFrame: Duration of ICU stay, average of 24 hours
measure: Length of hospital stay
timeFrame: Duration of hospital stay, expected average 5 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Karim ASEHNOUNE, PhD, MD
role: STUDY_CHAIR
References:
citation: Ziai WC, Varelas PN, Zeger SL, Mirski MA, Ulatowski JA. Neurologic intensive care resource use after brain tumor surgery: an analysis of indications and alternative strategies. Crit Care Med. 2003 Dec;31(12):2782-7. doi: 10.1097/01.CCM.0000098860.52812.24.