Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients

Stroke Clinical Trial

— NORMONICU  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06367543
• Other study ID #: AZ 117/22
• Status: Active, not recruiting
• Start date: November 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 474
• Est. completion date: December 31, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Diagnostic Test:
• Time in therapeutic range of vital parameters
Treatment adherence on NICU to the following vital parameters: Temperature (T<37,5°C) (every 4 hours during the first 96 h after admission to neurocritical care unit) 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) Mean arterial blood pressure (MAP: 60-90 mmHg) (every 4 hours during the first 96 h after admission to neurocritical care unit) Arterial oxygen partial pressure (paO2: 75 - 100 mmHg) (every 4 hours during the first 96 h after admission to neurocritical care unit) Arterial carbon dioxide partial pressure (paCO2: 35 - 45 mmHg). (every 4 hours during the first 96 h after admission to neurocritical care unit) Blood glucose (BG: 80-180 mg/dL). (every 4 hours during the first 96 h after admission to neurocritical care unit)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Gießen	Gießen	Hessen

Sponsors (8)

Lead Sponsor	Collaborator
University of Giessen	Heidelberg University, Technical University of Munich, University Hospital, Essen, University of Cologne, University of Leipzig, University of Mannheim, University of Wuerzburg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in Therapy range	Percentage of patients within treatment range for the primary intervention measured parameters every 4 hours during the first 96 hours after admission to neurocritical care unit: Body temperature < 37,5 degrees celsius.; Systolic blood pressure range by patients with ischemic stroke (120-180 mmHg; systolic blood pressure range by patients with hemorrhagic stroke (100-140 mmHg.; Mean blood pressure range in all patients (60-90 mmHg).; Serum blood glucose range (80-180 mg/dL).; Arterial oxygen partial pressure paO2 range (75-100 mmHg); Arterial carbon dioxide partial pressure (paCO2) range (35-45 mmHg).	every 4 hours during the first 96 hours after admission to neurocritical care unit.
Secondary	Acute measures	Percentage of participant with preclinical intubation.; Percentage of participants who received intravenous thrombolysis; Percentage of participants who received mechanical thrombectomy with TICI grading (Thrombolysis in cerebral infarction (TICI) scale), (minimum value of 0 and maximum value of 3; higher scores mean better outcome).; Percentage of participants who received Clipping/Coiling during the stay at the neurocritical care unit.; Percentage of participant who received surgical hematoma evacuation during the stay at the neurocritical care unit.	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.
Secondary	Invasive measures performed in the course of the Stay	Active cooling system. (Percentage of participants with active cooling system from the whole study population).; Percentage of participants who received invasive (Cooling catheter for temperature management).; Percentage of participants who received surface cooling pads.; Percentage of participant with Placement of EVD (External ventricular drain); Percentage of participants with placement of lumbar drain.	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.
Secondary	Duration of ventilation	Duration of ventilation measured in hours.	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.
Secondary	Deceased on Intensive Care.	Death on neurocritical care Unit.	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.
Secondary	NIHSS (National Institutes of Health Stroke Scale).	NIHSS (National Institutes of Health Stroke Scale) on discharge or transfer. (minimum value of 0 and maximum value of 42; higher scores mean worse outcome) on discharge or transfer.	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.

External Links

•   Guidelines of the German Society of Neurology for the acute treatment of ischemic stroke
•   Guidelines of the German Society of Neurology for the treatment of intracerebral hemorrhage