Clinical trial NCT06367543: Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients
Official title: Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients: German-wide Observational Multicenter Individual Participant Data Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: neurocritical care unit
guideline adherence
stroke
intracerebral hemorrhage
ischemic stroke
targeted management
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: University of Leipzig
name: University of Wuerzburg
name: Technical University of Munich
name: Heidelberg University
name: University of Cologne
name: University of Mannheim
name: University Hospital, Essen
First posted: 2024-04-16
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted with the diagnosis of stroke treated on NICU will be included.

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 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.

Eligibility criteria: Inclusion Criteria:

* Age above 18
* acute neurovascular disease, i.e. cerebral ischemia, intracerebral hemorrhage or subarachnoid hemorrhage (International Classification of diseases, ICD10, i.e. 160.x, 161.x, 163.x).
* neurocritical care admission due to intubation and controlled ventilation Stay ≥ 4 days at the ICU.
* Hospital stay on NICU of a minimum of 4 days.

Exclusion Criteria:

Patients who received initial do-not-treat/do-not-resuscitate (DNT/DNR) orders as well as those who deceased within 24 hours after admission were not enrolled

Primary outcomes:
measure: Time in Therapy range
timeFrame: every 4 hours during the first 96 hours after admission to neurocritical care unit.
Secondary outcomes:
measure: Acute measures
timeFrame: From date of admission to the neurocritical care unit until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days.
measure: Invasive measures performed in the course of the Stay
timeFrame: From date of admission to the neurocritical care unit until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days.
measure: Duration of ventilation
timeFrame: From date of admission to the neurocritical care unit until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days.
measure: Deceased on Intensive Care.
timeFrame: From date of admission to the neurocritical care unit until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days.
measure: NIHSS (National Institutes of Health Stroke Scale).
timeFrame: From date of admission to the neurocritical care unit until the date of discharge or date of death from any cause, whichever came first, assessed up to 90 days.
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
state: Hessen
Study officials:
References:
citation: Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.
citation: Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
citation: Mullhi RK, Singh N, Veenith T. Critical care management of the patient with an acute ischaemic stroke. Br J Hosp Med (Lond). 2021 Jan 2;82(1):1-9. doi: 10.12968/hmed.2020.0123. Epub 2021 Jan 18.
citation: Sharma D, Smith M. The intensive care management of acute ischaemic stroke. Curr Opin Crit Care. 2022 Apr 1;28(2):157-165. doi: 10.1097/MCC.0000000000000912.