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Mild Hypothermia During Intracranial Aneurysm Clipping

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal

Status
Withdrawn
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Mild hypothermia
Sponsored by
University Hospital Hradec Kralove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Microcirculation, Mild Hypothermia, Induced, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Clipping, Vasospasms

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Known cryoglobulinemia

Sites / Locations

  • University Hospital Hradec Kralove

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mild hypothermia

Normothermia

Arm Description

After 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.

The body temperature will be maintained in the range 35,8° C - 36,8° C.

Outcomes

Primary Outcome Measures

Changes in Sidestream Dark Field (SDF) imaging variables
brain microcirculation will be measured by sidestream-dark field imaging (SDF) probe

Secondary Outcome Measures

Changes in diameter of small brain arteries at operating site
will be measured by SDF probe
Occurrence of vasospasms
measured by transcranial Doppler

Full Information

First Posted
August 27, 2015
Last Updated
October 17, 2016
Sponsor
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT02544256
Brief Title
Mild Hypothermia During Intracranial Aneurysm Clipping
Official Title
Mild Hypothermia During Intracranial Aneurysm Clipping: Effect on Brain Microcirculation and Postoperative Vasospasms in Patients With Ruptured Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
higher mortality in another published study
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Hradec Kralove

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 measured by transcranial Doppler.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal
Keywords
Microcirculation, Mild Hypothermia, Induced, Subarachnoid Hemorrhage, Aneurysmal, Aneurysmal Clipping, Vasospasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild hypothermia
Arm Type
Experimental
Arm Description
After 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.
Arm Title
Normothermia
Arm Type
No Intervention
Arm Description
The body temperature will be maintained in the range 35,8° C - 36,8° C.
Intervention Type
Procedure
Intervention Name(s)
Mild hypothermia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Sidestream Dark Field (SDF) imaging variables
Description
brain microcirculation will be measured by sidestream-dark field imaging (SDF) probe
Time Frame
1 and 2 hours after skin incision
Secondary Outcome Measure Information:
Title
Changes in diameter of small brain arteries at operating site
Description
will be measured by SDF probe
Time Frame
1 and 2 hours after skin incision
Title
Occurrence of vasospasms
Description
measured by transcranial Doppler
Time Frame
within the first 14 days after surgery
Other Pre-specified Outcome Measures:
Title
Days of hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Title
Glasgow outcome score (GOS) on discharge
Time Frame
2 weeks after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute subarachnoidal hemorrhage based on ruptured aneurysm Hunt and Hess scale 1-4 Clipping up to 72 hours after the rupture Exclusion Criteria: Known cryoglobulinemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlasta Dostalova, MD, PhD
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic

12. IPD Sharing Statement

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Mild Hypothermia During Intracranial Aneurysm Clipping

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