A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia.

This study has been completed.
Sponsor:
Information provided by:
University of Sarajevo
ClinicalTrials.gov Identifier:
NCT01206283
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

September 20, 2010
September 20, 2010
January 2006
June 2008   (final data collection date for primary outcome measure)
Mortality rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Measurement of outcome was done using the Glasgow Outcome Scale (GOS) after each specific intervention in all the patients. GOS 1 - dead, 2- vegetative, 3- severe disabled, 4- moderate disabled, 5- independent.
Same as current
No Changes Posted
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A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia.
Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy: A Randomized Controlled Study in Patients With Secondary Brain Ischaemia.

Secondary brain ischaemia (SBI) usually develops after aneurysmal subarachnoid haemorrhage (SAH) and severe traumatic brain injury (TBI). The current management strategies are based on intracranial pressure-targeted therapy (ICP-targeted) with cerebral microdialysis monitoring (modified Lund concept) or cerebral perfusion pressure-targeted therapy (CPP-targeted). We present a randomised controlled study to compare the two management strategies.

The hypotheses of the study were:

  • SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics and any treatment applied will essentially treat the same underlying pathophysiology.
  • ICP-targeted therapy with cerebral microdialysis monitoring according to the modified Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI after aneurysmal SAH and severe TBI.

Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted therapy groups. Mortality rates in both groups were calculated and biochemical signs of cerebral ischaemia were analysed using cerebral microdialysis. Outcome for cerebral microdialysis was measured as poor outcome (Glasgow Outcome Scale score 1, 2 and 3) or good outcome (Glasgow Outcome Scale score 4 and 5).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Brain Injuries
  • Subarachnoid Hemorrhage
  • Procedure: Modified Lund concept

    After surgical evacuation of intracranial mass lesion and clipping of aneurysm the objectives were achieved:

    • Reduction of cerebral energy metabolism with fentanyl (2-5 µg/kg/h) and thiopenthal (0.5-3 mg/kg/h);
    • Maintenance of colloid osmotic pressure with administration of red cell and albumin/plasma transfusions to maintain Hb/s 125-140 g/L and Alb/s ≈40 g/L;
    • Reduction of capillary hydrostatic pressure with α2-agonist clonidine (0.4-0.8 µg/kg, 1 x 4-6 iv.) and maintaining normovolaemia;
    • Reduction of mean arterial pressure and neuroprotection with Nimodipine infusion 5 ml per hour for 21 days and Urapidil 200 mg /200 ml, 7-10 ml/h.
    • Control of ICP, which can be in majority of patients, kept at values below 15 mmHg.
  • Procedure: Cerebral perfusion pressure-targeted therapy
    • ICP monitoring using an external ventricular drain and CSF drainage as a first measure if ICP was increased (over 15-20 mmHg);
    • Maintenance of CPP over 70-80 mmHg (Triple 'H' therapy = 3L/24 hours including 1L of colloids - 5% albumin; drugs = dopamine, dobutamine);
    • No hyperventilation if ICP was under 20-25 mmHg and hyperventilation as a third measure if ICP was increased;
    • Osmotherapy (20% manitol, bolus 150-350 ml or 10% manitol, 50 ml/h for 10 hours and standard electrolytes [Na, Cl and K]);
  • Active Comparator: Cerebral perfusion pressure-targeted
    15 comatose operated patients after aneurysmal subarachnoid haemorrhage and severe traumatic brain injury respectively were managed postoperatively using cerebral perfusion pressure-targeted therapy according to the American Associations of Neurological Surgeons. Results were categorised into different Glasgow Outcome Scores.
    Intervention: Procedure: Cerebral perfusion pressure-targeted therapy
  • Active Comparator: Intracranial pressure-targeted therapy
    Intervention: Procedure: Modified Lund concept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with subarachnoid haemorrhage who had anterior circulation aneurysm rupture only
  • multiple anterior aneurysm rupture
  • severe traumatic brain injury with isolated head injury and intradural focal lesions only

Exclusion Criteria:

  • Glasgow Outcome Score of 3 with or without brainstem reflexes
  • Significant co-morbidities
  • posterior circulation aneurysm
  • multisystem injuries
  • diffuse axonal injuries
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Bosnia and Herzegovina
 
NCT01206283
030531674
Yes
Kemal Dizdarevic, Clinical Center University of Sarajevo, Bosnia and Herzegovina
University of Sarajevo
Not Provided
Principal Investigator: Kemal Dizdarevic, MD, MSc, PhD Department of Neurosurgery, Clinical Centre University of Sarajevo, Sarajevo, Bosnia and Herzegovina
University of Sarajevo
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP