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

Brain Injuries Clinical Trial

Official title:

Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy: A Randomized Controlled Study in Patients With Secondary Brain Ischaemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206283
• Other study ID #: 030531674
• Status: Completed
• Phase: N/A
• First received: September 20, 2010
• Last updated: September 20, 2010
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: September 2010
• Source: University of Sarajevo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia: Federal Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Brain Ischemia
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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 a2-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.
• 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]);

Locations

Country	Name	City	State
Bosnia and Herzegovina	Department of Neurosurgery, Clinical Centre University of Sarajevo	Sarajevo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sarajevo

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	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.	18 months	No