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Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Optimum Duration of Hypercapnia

Primary Purpose

Vasospasm Intracranial

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Temporary hypercapnia
Sponsored by
University of Wuerzburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasospasm Intracranial focused on measuring SAH, Hypercapnia, DCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aneurysmal SAH
  • Aneurysm occluded by clipping/coiling within 96 hours
  • Hunt/Hess 3-5
  • Fisher 2-4 on initial CT scan
  • Intubated, sedated and mechanically ventilated patient
  • Continous drainage of cerebrospinal fluid (CSF)

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy
  • Common obstructive lung disease (COLD)
  • potential of hydrogen (pH) in ABG < 7,25
  • ICP > 20 mmHg

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Optimum duration of hypercapnia

    Arm Description

    Daily serial measurement of 2 hours under target hypercapnia of pCO2 50 - 55 mmHg by changes of respirator settings once per day

    Outcomes

    Primary Outcome Measures

    Cerebral blood flow (CBF)
    Changes of CBF (absolute, ml/100g tissue/min) under changes of arterial pCO2

    Secondary Outcome Measures

    Cerebral tissue oxygen saturation
    Changes of tissue oxygen saturation measured by near-infrared spectroscopy (NIRS)
    Glasgow Outcome Score (GOS)
    Glasgow Outcome Score (GOS 1 - 5, GOS 1 = Death, GOS 5 = none or low disability) after 14 days, after discharge and 6 months

    Full Information

    First Posted
    December 22, 2020
    Last Updated
    December 28, 2020
    Sponsor
    University of Wuerzburg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04687605
    Brief Title
    Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Optimum Duration of Hypercapnia
    Official Title
    Therapeutic Hypercapnia After Aneurysmal Subarachnoid Hemorrhage - Study for the Optimum Duration of Hypercapnia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Wuerzburg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Temporary hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). The aim of this study now was to measure the course of carbon dioxide partial pressure (pCO2) reactivity after prolonged hypercapnia, and to evaluate the therapeutic effect of graded hypercapnia.
    Detailed Description
    Cerebral vasospasm still is the leading cause of delayed cerebral ischemia (DCI) and secondary ischemic deficits after aneurysmal subarachnoid hemorrhage (SAH). Hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). Furthermore, the increase of CBF and StiO2 sustained after normalization of ventilation and no rebound effect was found. So, a possible optimization of the hypercapnic period may lead to prolonged effects of increased CBF and StiO2. Aim of this stuy is to find the ideal duration of hypercapnia and to evaluate the therapeutic effect of graded hypercapnia. For this, intubated and mechanically ventilated patients with an aneurysmal SAH Hunt/Hess 3-5, Fisher grade 2-4 on the initial CT scan and supplied with an external ventricular drainage will be included within the first 96 hours after ictus. Between day 4 and 14 they undergo a trial intervention in which the respiratory minute volume will be reduced in order to maintain a target PaCO2 of 50 - 55 mmHg for 2 hours. Arterial blood gas analysis (ABG) and transcranial Doppler sonography (TCD) is performed in 15-minute intervals. Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cardiovascular parameters are monitored continuously, serial measurement of CBF and StiO2 under continous hypercapnia is performed. Primary endpoint of this trial is change of CBF under hypercapnia, secondary endpoints are StiO2, measures non-invasively with near-infrared spectroscopy, mean flow velocity of intracranial vessels in TCD, delayed cerebral infarction in cranial CT and Glasgow Outcome Score (GOS) after 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vasospasm Intracranial
    Keywords
    SAH, Hypercapnia, DCI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Optimum duration of hypercapnia
    Arm Type
    Experimental
    Arm Description
    Daily serial measurement of 2 hours under target hypercapnia of pCO2 50 - 55 mmHg by changes of respirator settings once per day
    Intervention Type
    Procedure
    Intervention Name(s)
    Temporary hypercapnia
    Intervention Description
    Temporary daily hypercapnia for 2 hours between day 4 and 14 after SAH
    Primary Outcome Measure Information:
    Title
    Cerebral blood flow (CBF)
    Description
    Changes of CBF (absolute, ml/100g tissue/min) under changes of arterial pCO2
    Time Frame
    2-4 hours, day 4-14 after SAH
    Secondary Outcome Measure Information:
    Title
    Cerebral tissue oxygen saturation
    Description
    Changes of tissue oxygen saturation measured by near-infrared spectroscopy (NIRS)
    Time Frame
    2-4 hours, day 4-14 after SAH
    Title
    Glasgow Outcome Score (GOS)
    Description
    Glasgow Outcome Score (GOS 1 - 5, GOS 1 = Death, GOS 5 = none or low disability) after 14 days, after discharge and 6 months
    Time Frame
    up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aneurysmal SAH Aneurysm occluded by clipping/coiling within 96 hours Hunt/Hess 3-5 Fisher 2-4 on initial CT scan Intubated, sedated and mechanically ventilated patient Continous drainage of cerebrospinal fluid (CSF) Exclusion Criteria: Age under 18 years Pregnancy Common obstructive lung disease (COLD) potential of hydrogen (pH) in ABG < 7,25 ICP > 20 mmHg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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