Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367543
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-13
Brief Title:
Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients
Sponsor:
University of Giessen
Organization:
University of Giessen
Study Overview
Official Title:
Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients German-wide Observational Multicenter Individual Participant Data Meta-analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NORMONICU
Brief Summary:
The aim of the planned study project is to assess the current situation regarding the treatment of patients with severe stroke at the neuro-critical care unit Specifically determination of whether the target parameters recommended in the guidelines for temperature systolic blood pressure mean arterial blood pressure blood glucose arterial oxygen partial pressure and arterial carbon dioxide partial pressure had to be maintained From the planned data analysis the need for the introduction of cerebrovascular bundles can be derived and planned
Detailed Description:
Cerebrovascular events include cerebral infarctions as well as intracranial haemorrhages If the severity of this cerebrovascular damage is so severe functional damage to the brain occurs which must be treated regularly in intensive care In particularly severe cases patients are analgosedated intubated and ventilated to treat elevated intracranial pressure ICP Especially in these critically ill patients it is known from numerous studies that adherence to normal physiological parameters of body temperature blood pressure serum glucose and ventilation parameters leads to an improvement in the outcome of the patients This has led to the corresponding guidelines for the treatment of these patients
In the case of patients with sepsis it is known that a scientifically proven finding of a better treatment option did not directly lead to an implementation in daily patient care Only the introduction of treatment and target bundles as a combination of such interventions then led to the implementation of the recommendations and to an improvement in patient care From this background the question arises as to whether the above-mentioned measures have been implemented in neurological intensive care medicine for patients with severe cerebrovascular diseases or whether measures such as the introduction and training of target bundles could be useful
The aim of this research project is to generate new evidence for or against common treatment algorithms in fields where no randomized data are available Among other things it will be analysed to what extent early management on intensive care units affect outcomerelevant parameters The overall aim is to improve the current level of evidence on the management of patients with severe stroke by analyzing a large database of individualized patient data
The aim of the planned study project is a national multicentre retrospective collection of real patient data in specialized neurologicalneurosurgical intensive care units of patients with severe cerebrovascular diseases From these collected data the reality of treatment is to be presented and guideline adherence is to be calculated From the planned data analysis the need for the introduction of cerebrovascular bundles can be derived and planned
Specifically a retrospective evaluation of patients who were hospitalized at eight neurocritical care units in eight tertiary centres in Germany Specifically it is planned to first identify these patients through a controlling query Subsequently various clinical parameters from the routine acute phase will be collected by reviewing the in-house electronic data systems Aspects of data protection will be observed according to the local institutional guidelines
In the case of patients with sepsis it is known that a scientifically proven finding of a better treatment option did not directly lead to an implementation in daily patient care Only the introduction of treatment and target bundles as a combination of such interventions then led to the implementation of the recommendations and to an improvement in patient care From this background the question arises as to whether the above-mentioned measures have been implemented in neurological intensive care medicine for patients with severe cerebrovascular diseases or whether measures such as the introduction and training of target bundles could be useful
The aim of this research project is to generate new evidence for or against common treatment algorithms in fields where no randomized data are available Among other things it will be analysed to what extent early management on intensive care units affect outcomerelevant parameters The overall aim is to improve the current level of evidence on the management of patients with severe stroke by analyzing a large database of individualized patient data
The aim of the planned study project is a national multicentre retrospective collection of real patient data in specialized neurologicalneurosurgical intensive care units of patients with severe cerebrovascular diseases From these collected data the reality of treatment is to be presented and guideline adherence is to be calculated From the planned data analysis the need for the introduction of cerebrovascular bundles can be derived and planned
Specifically a retrospective evaluation of patients who were hospitalized at eight neurocritical care units in eight tertiary centres in Germany Specifically it is planned to first identify these patients through a controlling query Subsequently various clinical parameters from the routine acute phase will be collected by reviewing the in-house electronic data systems Aspects of data protection will be observed according to the local institutional guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None