NCT06367543

Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients

Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients: German-wide Observational Multicenter Individual Participant Data Meta-analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 474 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 neurological/neurosurgical 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.

Conditions

• Stroke

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Time in therapeutic range of vital parameters	Treatment adherence on NICU to the following vital parameters: 1. Temperature (T\<37,5°C) (every 4 hours during the first 96 h after admission to neurocritical care unit) 2. systolic blood pressure ICD-10 (International Statistical Classification of Diseases 10th Revision) (I60, 161 \& 162): 100-140 mmHg ICD-10 (I63): 120-180 mmHg (every 4 hours during the first 96 h after admission to neurocritical care unit) 3. Mean arterial blood pressure (MAP: 60-90 mmHg) (every 4 hours during the first 96 h after admission to neurocritical care unit) 4. Arterial oxygen partial pressure (paO2: 75 - 100 mmHg) (every 4 hours during the first 96 h after admission to neurocritical care unit) 5. Arterial carbon dioxide partial pressure (paCO2: 35 - 45 mmHg). (every 4 hours during the first 96 h after admission to neurocritical care unit) 6. Blood glucose (BG: 80-180 mg/dL). (every 4 hours during the first 96 h after admission to neurocritical care unit)

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2024-04-16
• Last updated: 2025-04-06

Locations

1 site across 1 country: Germany