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

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 16 to 70 years
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Brain Injuries, Subarachnoid Hemorrhage

Being tested

Modified Lund concept, Cerebral perfusion pressure-targeted therapy

Keywords

traumatic brain injury, subarachnoid hemorrhage, secondary brain ischemia, microdialysis, modified Lund concept, cerebral perfusion pressure, intracranial pressure

Medical subject headings

Brain Injuries, Subarachnoid Hemorrhage, Brain Injuries, Traumatic

What participants receive

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

• Modified Lund conceptProcedure or surgery

  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.

• Cerebral perfusion pressure-targeted therapyProcedure or surgery

  • 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]);

What is being measured

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

1. 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.

   Measured: 18 months

Timeline

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

1. First posted21 Sep 2010 (estimated)
2. Study startJan 2006
3. Primary completionJun 2008
4. Study completionJul 2008

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Brain InjuriesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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