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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01801813
Other study ID # RC12_0416
Secondary ID
Status Completed
Phase N/A
First received February 15, 2013
Last updated August 9, 2017
Start date January 2013
Est. completion date November 2015

Study information

Verified date March 2016
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 795
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 15 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients undergoing neuro-surgery for a brain tumor

Exclusion Criteria:

- Neuro-surgical emergency

Study Design


Intervention

Other:
Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications


Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative complications requiring Neuro-ICU stay = 24 hours after surgery for neurosurgical reason. During ICU stay, average of 24 hours
Secondary Describing post-operative complications in patients undergoing neuro-surgery for brain tumor. 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. During ICU stay, average of 24 hours
Secondary Duration of mechanical ventilation Duration of mechinal ventilation, average of 12 hours
Secondary Length of ICU stay Duration of ICU stay, average of 24 hours
Secondary Length of hospital stay Duration of hospital stay, expected average 5 days
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