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Completed

NCT Number: NCT06367543

Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Gießen

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time in therapeutic range of vital parameters

Diagnostic Test

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)

Other names: Treatment adherence on NICU

Primary outcomes

  1. Time in Therapy range

    Time frame: every 4 hours during the first 96 hours after admission to neurocritical care unit.

    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).

Secondary outcomes

  1. Acute measures

    Time frame: 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.

    • 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.

  2. Invasive measures performed in the course of the Stay

    Time frame: 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.

    • 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.

  3. Duration of ventilation

    Time frame: 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.

    Duration of ventilation measured in hours.

  4. Deceased on Intensive Care.

    Time frame: 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.

    Death on neurocritical care Unit.

  5. NIHSS (National Institutes of Health Stroke Scale).

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Heidelberg University
  • Technical University of Munich
  • University Hospital, Essen
  • University of Cologne
  • University of Leipzig
  • University of Mannheim
  • University of Wuerzburg

Registry information

Official study title

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

Acronym: NORMONICU

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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