Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients (NORMONICU)

April 2, 2025 updated by: University of Giessen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

474

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • Universitätsklinikum Giessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All patients admitted with the diagnosis of stroke treated on NICU will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with stroke admitted to an NICU
Patients with neurovascular disease necessitating NICU-treatment. Neurovascular disease includes all stroke subcategorized into ischemic stroke and hemorrhagic stroke (i.e. subarachnoid hemorrhage and intracerebral hemorrhage)
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)
Other Names:
  • Treatment adherence on NICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
every 4 hours during the first 96 hours after admission to neurocritical care unit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
  1. Percentage of participant with preclinical intubation.
  2. Percentage of participants who received intravenous thrombolysis
  3. 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).
  4. Percentage of participants who received Clipping/Coiling during the stay at the neurocritical care unit.
  5. 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.
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.

  1. 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.
  2. Percentage of participant with Placement of EVD (External ventricular drain)
  3. 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.
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.
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.
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.
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).
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 117/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Time in therapeutic range of vital parameters

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe