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Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. Increased water content in the injured brain can be related to a vasogenic or cellular pathway. Osmotherapy, by using mannitol or hypertonic saline (HSS), is recommended and currently administered for the treatment of ICH in this setting. Beside these two usual treatments, sodium lactate (SL), a metabolic and neuroprotective solution, has recently been described as having similar effects on lowering intracranial pressure (ICP). In a previous study, conducted in patients with severe TBI, (1) Ichai et al. reported that a bolus of half-molar SL was as effective than equimolar doses of mannitol to reduce elevated ICP (less refractory ICH and higher and longer reduction of ICH).
Objective(s):
The purpose of the study is to analyze the effect on ICH of SL compared to a hypertonic saline solution (HSS).
Outcome(s):
The primary endpoint is the efficacy in lowering ICH after 4 h. Secondary endpoints were percentage of successfully treated episodes of intracranial hypertension and neurological status at discharge from ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lactate sodium | Experimental | 100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter |
|
| Hypertonic Saline solution | Active Comparator | single infusion of 100 mL of 7.5% saline (osmolarity, 2560 mOsm/L) (HSS group)in 15 mins of administration via a central venous catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactate, Sodium | Drug | Isovolemic and osmotic infusion Comparison of osmotic agent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| intracranial pressure (ICP) | Invasive monitoring of intracranial pressure | 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successfully treated episodes | decrease of ICP >5mmHg or level <20mmHg | 48 hours |
| Oxygen tissular pressure | In vasive measurement of tissular pressure |
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Inclusion Criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Herve Quintard, MD, PhD | Contact | +41795532188 | herve.quintard@hcuge.ch | |
| aurélie Perret | Contact | +41795530805 | aurelie.perret@hcuge.ch |
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A prospective open randomized single center study comparing Sodium lactate (SL) to Hypertonic Saline Solution (HSS) in brain injured adult ICU
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| Hypertonic saline |
| Drug |
Isovolemic and osmotic infusion Comparison of osmotic agent |
|
| 240 minutes |
| Neurological status at discharge of ICU | Measurement Glasgow Outcome Scale | through study completion, an average of 30 days |
| Number of episodes of intracranial hypertension | Number of episodes of intracranial hypertension | through study completion, an average of 30 days |
| ID | Term |
|---|---|
| D019354 | Sodium Lactate |
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D007773 | Lactates |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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