Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04687605 |
| Other study ID # |
AZ230/14 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
December 2020 |
| Source |
University of Wuerzburg |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
