Effects of mannitol and hypertonic saline on cerebral oxygenation and metabolism in patients with posttraumatic intracranial hypertension.

Effects of mannitol and hypertonic saline on cerebral oxygenation and metabolism in patients with posttraumatic intracranial hypertension. - mannitol and hypertonic saline in patients after traumatic brain injury.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30018

Enrollment

Registered

2007-07-17

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain swelling intracranial hypertension

Interventions

Patients are randomized to treatment with 250 mOsm HS or mannitol via a central venous catheter over 5 minutes. The treatment will be administered if the intracranial pressure is > 25 mm Hg for at l

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients Severe traumatic brain injury (Glasgow Coma Scale at first presentation 20 mm Hg)

Exclusion criteria

Exclusion criteria: No informed consent from the patient*s legal representative. Expected survival

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study will be cerebral oxygenation as measured by intracerebral PO2 (expressed as mmHg).	—

Secondary

Measure	Time frame
Secondary endpoints will be cerebral blood flow, metabolism and inflammation. Cerebral blood flow will be measured by transcranial Doppler and expressed as flow in cm/sec. The balance between aerobic and anaerobic metabolism will be determined by measuring intraparenchymal lactate/pyruvate ratio using cerebral microdialysis. Components of the inflammatory response such as the pro- and anti-inflammatory cytokines IL-6, TNF-a and IL-10 will be measured in blood from the jugular bulb.	—

Measure

Time frame

Secondary endpoints will be cerebral blood flow, metabolism and inflammation. Cerebral blood flow will be measured by transcranial Doppler and expressed as flow in cm/sec. The balance between aerobic and anaerobic metabolism will be determined by measuring intraparenchymal lactate/pyruvate ratio using cerebral microdialysis. Components of the inflammatory response such as the pro- and anti-inflammatory cytokines IL-6, TNF-a and IL-10 will be measured in blood from the jugular bulb.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)