Effects of Tromethamine on Brain Oxygenation and Metabolism in Patients Suffering Intractable Intracranial Hypertension – an exploratory study.

Effects of Tromethamine on Cerebral Oxygenation and Metabolism in Patients Suffering Intractable Intracranial Hypertension – an exploratory study. - Effect of Tromethamine on Cerebral Oxygenation

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001863-35-AT

Enrollment

Unknown

Registered

2016-06-28

Start date

2016-06-21

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

Critically ill patients (SAH, ICB, AVM bleedings, malignant MCA infarcts) under sedation and mechanical ventilation in need of multimodality monitoring, including brain tissue oxygen monitoring and microdialysis. In this population, elevated intracranial pressure (ICP) remains a major complication. As salvage therapy of intractable intracranial hypertension Tromethamine is often administered in an off-label indication for lowering ICP.

Interventions

Trade Name: Tris 36,34% Braun Product Name: Tris 36,34% Braun Product Code: 6723632.00.00 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: TROMETAMOL CAS Number: 77-86-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - age > 18 years - patient is in need of multimodality monitoring, including ICP, regional brain tissue oxygen tension (ptiO2) measurement and microdialysis - Clinical indication for THAM administration for treatment of intractable intracranial hypertension (ICP > 20mmHg) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Patient age 7,5 - no need of multimodality monitoring - mannitol administration within the last 3 hours (half-life time of 100min) - immediate need for concomitant administration of mannitol

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 10, 30 and 60 minutes after tromethamine administration;Main Objective: We propose to investigate effects of tromethamine on ICP and regional brain tissue oxygen tension (ptiO2) as measured by Neurovent PTO microprobes in critically ill patients under sedation and mechanical ventilation at a neurosurgical ICU suffering with acute intractable ICP elevation.;Primary end point(s): ptiO2 10, 30 and 60 minutes after tromethamine administration;Secondary Objective: effects of tromethamine 10, 30 and 60 minutes after first bolus administration on: intracranial pressure mean arterial pressure cerebral perfusion pressure cerebral metabolism measured by cerebral microdialysis (glucose, lactate, pyruvate, glycerol, and glutamate) TCD flow velocities arterial blood gas values (pH, pCO2, pO2, bicarbonate, base excess) dosage and frequency of tromethamine administration concomitant medication for ICP control	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 10, 30 and 60 minutes after tromethamine administration;Main Objective: We propose to investigate effects of tromethamine on ICP and regional brain tissue oxygen tension (ptiO2) as measured by Neurovent PTO microprobes in critically ill patients under sedation and mechanical ventilation at a neurosurgical ICU suffering with acute intractable ICP elevation.;Primary end point(s): ptiO2 10, 30 and 60 minutes after tromethamine administration;Secondary Objective: effects of tromethamine 10, 30 and 60 minutes after first bolus administration on: intracranial pressure mean arterial pressure cerebral perfusion pressure cerebral metabolism measured by cerebral microdialysis (glucose, lactate, pyruvate, glycerol, and glutamate) TCD flow velocities arterial blood gas values (pH, pCO2, pO2, bicarbonate, base excess) dosage and frequency of tromethamine administration concomitant medication for ICP control

—

Secondary

Measure	Time frame
Secondary end point(s): intracranial pressure mean arterial pressure cerebral perfusion pressure cerebral metabolism measured by cerebral microdialysis (glucose, lactate, pyruvate, glycerol, and glutamate) TCD flow velocities arterial blood gas values (pH, pCO2, pO2, bicarbonate, base excess) ;Timepoint(s) of evaluation of this end point: 10, 30 and 60 minutes after tromethamine administration	—

Countries

Austria

Contacts

Public ContactSecretary

Medical University Vienna, Department of Clinical Pharmacology

004314040029810

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026