Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients

NCT06367543 | Completed

• 1 other identifier: AZ 117/22
• Study Type: observational
• Target: 474
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

neurocritical care unit; guideline adherence; stroke; intracerebral hemorrhage; ischemic stroke; targeted management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Acute measures

  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

  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

  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.

  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).

  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.

Study Arms (1)

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

Interventions

Time in therapeutic range of vital parameters DIAGNOSTIC_TEST

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)

Also known as: Treatment adherence on NICU

Patients with stroke admitted to an NICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead
• University of Leipzig: collaborator
• University of Wuerzburg: collaborator
• Technical University of Munich: collaborator
• Heidelberg University: collaborator
• University of Cologne: collaborator
• University of Mannheim: collaborator
• University Hospital, Essen: collaborator

Study Sites (1)

Universitätsklinikum Gießen

Giessen, Hesse, 35392, Germany

Location

Related Publications (4)

• 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.

  PMID: 29675566 BACKGROUND

• 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.

  PMID: 34599691 BACKGROUND

• 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.

  PMID: 33512282 BACKGROUND

• 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.

  PMID: 35034076 BACKGROUND

Related 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

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Ischemic Stroke

Interventions

Time

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 16, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)