AzTrials
AzTrials

Subarachnoid Hemorrhage, AneurysmalNCT02544256

Mild Hypothermia During Intracranial Aneurysm Clipping

A study testing Mild hypothermia in people with Subarachnoid Hemorrhage, Aneurysmal, run by University Hospital Hradec Kralove at 1 site in Czechia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether mild hypothermia causes reduction of vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of vasospasms during the period of 14 postoperative days… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subarachnoid Hemorrhage, Aneurysmal
What is being tested?
Mild hypothermia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCzechia
Study dates
Dec 2015to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute subarachnoidal hemorrhage based on ruptured aneurysm
  • Hunt and Hess scale 1-4
  • Clipping up to 72 hours after the rupture

Who cannot join

  • Known cryoglobulinemia

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • University Hospital Hradec Kralove

    Hradec Králové, 50005

Other trials in Czechia

About this study

Official title: Mild Hypothermia During Intracranial Aneurysm Clipping: Effect on Brain Microcirculation and Postoperative Vasospasms in Patients With Ruptured Aneurysms

The purpose of this study is to determine whether mild hypothermia causes reduction of vasoconstriction in microcirculation after clipping of aneurysms, and affects the blood flow in small diameter arteries at operating site (ischemia-hyperemia) and occurrence of vasospasms during the period of 14 postoperative days measured by transcranial Doppler.

Read the detailed description

Methods: All the patients meeting the study criteria will be randomized into two groups. Normothermia (NT) group : during the whole period of surgery the body temperature will be maintained in the range 35.8° C - 36.8° C. Hypothermia (HT) group: After induction to general anaesthesia the patients will be cooled to body temperature 33.8° C - 34.8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping. Warming up of the patients will start immediately afterwards. The target temperature at the time of extubation will be over 36° C in both groups (one of the extubation criteria).

Specific management: No pharmacological sedation (premedication) will be given to the patients. Cooling/warming mattress/blanket (PlastiPad® Blanketrol® III Cincinnati Sub-Zero, USA) will be placed on the operating table. Induction to general anesthesia will be with propofol 2 mg/kg/b.w i.v. (with possible adjustment according to age and/or physical status of the patient) and atracurium 0,5 mg/kg/b.w. i.v. After orotracheal intubation, the esophageal temperature probe will be inserted (depth of insertion 25 cm from the nostril). Afterwards, the envelope with randomization will be opened by the anaesthesiologist.

In HT group, the targeted body temperature will be set to 33° C and a bolus of saline 250 ml cooled to 5° C will be administered.

In NT group, the targeted body temperature will be set to 36° C and a bolus of saline 250 ml warmed to 37° C using infusion heater will be administered.

Standard preparation for the surgery will continue afterwards (insertion of central venous catheter, arterial catheter, urinary catheter). After finishing the preparation (coming of the surgeon), the infusion of mannitol 15% at the dose 0,5 g/kg i.v. is started and set for the duration of 40 minutes. Monitoring: basic monitoring (SpO2, ECG, end-tidal carbon dioxide (EtCO2), NIBP) together with extended monitoring (invasive blood pressure, response entropy/state entropy (RE/SE), neuromuscular transmission module (NMT), surgical plethysmography index (SPI).

Anesthesia management: Desflurane anesthesia in O2/air mixture with concentration of oxygen (FiO2) 0.45 will be used with targeted concentrations of desflurane according to the age groups initially (to achieve end-tidal concentration of desflurane 6 V%, 5.5 V%, 5 V%, 4.5 V%, and 4 V% in age groups 18 - 30, 30 - 40, 40 - 55, 55 - 65, and over 65 years respectively), further adjustment will be done to keep target RE/SE 40-50 in the individual patient. Analgesia will be provided by bolus i.v. administration of remifentanil 80 ug before induction, followed by continuous administration 0.25 ug/kg/min initially with further stepwise adjustment according to SPI (3-5 ml/hour steps). Target analgesia according to SPI is defined as the initial figure of SPI recorded 5 minutes after induction plus 10 points. Figures of SPI exceeding for 1 minute the target figure indicate the need of increasing the rate of remifentanil infusion. Atracurium boluses will be used for muscle relaxation, NMT monitoring by train of four (TOF) will be done in 5 minute intervals, TOF count over 1 indicating need of further atracurium bolus. Starting from dura mater suture, no further boluses of atracurium will be given.

Hemodynamic stability: Systolic and mean arterial pressures are maintained in the range of ± 15% of usually measured BP for individual patient. Decrease of BP bellow this figure in the duration of at least 5 minutes is indication for continuous administration of noradrenaline. Nimodipine is administered continuously during the whole procedure, infusion rate is set at the ICU, no adjustments are indicated at the OR. Volume therapy is provided by continuous balanced isotonic crystalloid infusion 5 ml/kg/h.

Microcirculation measurement: After craniotomy, microcirculation will be measured by SDF probe at the labelled sites of the brain (edge of craniotomy and at the distance of 2 cm from aneurysm). After aneurysm clipping, the measurement will be repeated at the same sites.

Finishing anaesthesia: At the beginning of skin suture, the remifentanil infusion is stopped. After finishing the skin suture, the administration of desflurane is stopped and end-tidal control flush out of desflurane is activated.

Extubation criteria: consciousness Glasgow coma scale (E-2-3/V-1-3/M-6), normotension including noradrenaline administration in stable continuous dose, normocapnia, spontaneous ventilation with respiratory rate (RR) over 10/minute, tidal volume (TV) 4-6 ml/kg, preserved coughing reflex, SpO2 over 95% without/with O2 administration, normothermia over 36° C, train of four ratio over 92%.

Being tested
Mild hypothermia
Keywords
Microcirculation, Mild Hypothermia, Induced, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Clipping, Vasospasms
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mild hypothermiaProcedure or surgery

    Mild hypothermia during surgical clipping of brain aneurysm will be reached by cooling to body temperature 33,8° C - 34,8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping.

Study groups in NCT02544256
Study groupRoleWhat they receive
Mild hypothermiaExperimentalAfter induction to general anaesthesia the patients will be cooled to 33° C. Targeted body temperature 33,8° C - 34,8° will be maintained up to the end of microcirculation measurement after aneurysm clipping.
Receives: Procedure: Mild hypothermia
NormothermiaNo interventionThe body temperature will be maintained in the range 35,8° C - 36,8° C.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Sidestream Dark Field (SDF) imaging variables

    brain microcirculation will be measured by sidestream-dark field imaging (SDF) probe

    Measured: 1 and 2 hours after skin incision

Secondary outcomes (2)
  1. Changes in diameter of small brain arteries at operating site

    will be measured by SDF probe

    Measured: 1 and 2 hours after skin incision

  2. Occurrence of vasospasms

    measured by transcranial Doppler

    Measured: within the first 14 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Why it stopped: higher mortality in another published study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02544256
Sponsor's protocol ID
201507-S16P
Status last verified
Oct 2016
First submitted
27 Aug 2015
Last updated
18 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Mild hypothermia in people with Subarachnoid Hemorrhage, Aneurysmal, run by University Hospital Hradec Kralove at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Sidestream Dark Field (SDF) imaging variables (time frame: 1 and 2 hours after skin incision). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in