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Table 15.19 Mannitol for the Multimodal Acute Management of Intracranial Pressure Post ABI

Author Year

Country

Research Design

PEDro

Sample Size

Methods Outcome

Ichai et al. (2009)

France

RCT

PEDro=6

N=34

Population: TBI; Mannitol (MAN, n=17): Mean Age=33.8 yr; Gender: Male=11, Female=6; Time Post Injury<8 hr; Median GCS=6. Sodium Lactate (SL, n=17): Mean Age=37.6 yr; Gender: Male=13, Female=4; Time Post Injury<8 hr; Median GCS=4.

Intervention: Patients were randomized to receive intravenous infusion of 20% MAN (1.5 mL/kg) and/or SL over 15 min.

Outcome Measure: Intracranial Pressure (ICP).

1.        Both treatments were effective in reducing ICP from baseline (p<0.0001).

2.        SL showed significantly lower ICP levels compared to MAN (p=0.016).

3.        The effect of SL alone on ICP was more pronounced (p=0.0061) and more prolonged (p=0.0049) than MAN alone.

4.        The percentage of episodes requiring rescue treatment was higher with mannitol than lactate (29.6% versus 9.6%, p=0.053).

Francony et al. (2008)

France

RCT

PEDro=6

N=20

Population: TBI=17, ABI=3. Mannitol (MAN, n=10): Mean Age=43 yr; Gender: Male=7, Female=3; Mean GCS=8; Mean Time Post Injury=6 days. Hypertonic Saline (HTS, n=10): Mean Age=37 yr; Gender: Male=9, Female=1; Mean GCS=7; Mean Time Post Injury=5d.

Intervention: Patients were randomized to receive a single intravenous infusion of 20% MAN (231 mL) or of 7.45% HTS (100 mL) administered over 20 min.

Outcome Measures: Intracranial Pressure (ICP), Mean Arterial Pressure (MAP), Cerebral Perfusion Pressure (CPP), Urine Output (UO), Serum Sodium/Chloride.

1.        ICP was reduced in both groups of patients following treatment.

2.        In MAN, ICP was significantly reduced by 45% of baseline values (-14mmHg,) at 60 min (p=0.01) and by 32% of baseline values (-10 mmHg) at 120 min (p=0.01).

3.        In HTS, ICP was significantly reduced by 35% of baseline values (-10mmHg) at 60 min (p=0.01) and by 23% of baseline values (-6 mmHg) at 120min (p=0.01).

4.        MAP was unchanged and comparable between groups (F=1.2, p=0.32).

5.        CPP was significantly elevated only in the MAN (p<0.05).

6.        MAN showed significantly greater increase in UO (p<0.05).

7.        HTS showed significantly greater increase in serum sodium and chloride after 120 min (p<0.01).

Cruz et al. (2004)

Brazil

RCT

PEDro=5

N=44

Population: TBI; High-Dose Mannitol (HDM, n=23): Mean Age=34 yr; Mean GCS=3. Conventional-Dose Mannitol (CDM, n=21): Mean Age=31 yr; Mean GCS=3.

Intervention: Patients were randomized to receive rapid intravenous infusion of HDM (up to 1.4 g/kg) or CDM (up to 0.7 g/kg). Both groups received normal saline infusions immediately after the mannitol infusions.

Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS), Mortality, Additional Therapy Required.

1.        At 6 mo, mortality rates were 39.1% and 66.7% for the HDM and CDM groups, respectively.

2.        Clinical outcome on the GOS was significantly better for the HDM group, with a greater number of patients in this group showing a favourable outcome (GOS>4) compared with the CDM group (43.5% versus 9.5%, p<0.02).

3.        No significant difference was found between the HDM and CDM groups in percentage of patients requiring decompressive surgery for refractory ICP elevations (43.5% versus 47.6%).

Cruz et al. (2002)

Brazil

RCT

PEDro=5

N=141

Population: TBI; High-Dose Mannitol (HDM, n=72): Mean Age=29 yr; Mean GCS=5.3. Conventional-Dose Mannitol (CDM, n=69): Mean Age=31 yr; Mean GCS=5.5.

Intervention: Patients were randomized to receive rapid intravenous infusion of HDM (up to 1.4 g/kg) or CDM (up to 0.7 g/kg).

Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS), Additional Therapy Required.

1.        At 6mo, mortality rates were 19.4% and 36.2% for the HDM and CDM groups, respectively.

2.        Clinical outcome on the GOS was significantly better for the HDM group, with a greater number of patients in this group showing favourable outcome (GOS>4) compared with the CDM group (61.1% versus 33.3%, p<0.005).

3.        A greater proportion of patients in the CDM group required decompressive surgery for refractory ICP elevations than the HDM group (24.6% versus 9.7%, p<0.03).

Cruz et al. (2001)

Brazil

RCT

PEDro=4

N=178

Population: TBI; High-Dose Mannitol (HDM, n=91): Mean Age=30 yr; Mean GCS=6. Conventional-Dose Mannitol (CDM, n=87): Mean Age=28 yr; Mean GCS=6.2.

Intervention: Patients were randomized to receive intravenous infusion of HDM (Conventional dose + 0.6 to 0.7 g/kg in the absence of pupillary widening or 1.2 to 1.4  g/kg with pupillary widening) or CDM (0.6-0.7 g/kg).

Outcome Measures: Intracranial Pressure (ICP), Glasgow Outcome Scale (GOS), Additional Therapy Required.

1.        At 6 mo, mortality rates were 14.3% and 25.3% for the HDM and CDM groups, respectively.

2.        Clinical outcome on the GOS was significantly better for the HDM group, with a greater number of patients in this group showing favourable outcome (GOS>4) compared with the CDM group (69.2% versus 46%, p<0.01).

3.        No significant difference between HDM and CDM groups in percentage of patients requiring barbiturate therapy for refractory ICP elevations (46.1% versus 54%).

Smith et al. (1986)

USA

RCT

PEDro=4

N=77

Population: TBI; Mean Age=27 yr; Gender: Male=60, Female=17; Time Post Injury ≤6 hr; GCS ≤8.

Intervention: Patients were randomized to receive intravenous infusion of mannitol based on careful monitoring (Group 1; n=37) or irrespective of monitoring (Group 2; n=40). For Group 1, an initial bolus of 20% mannitol (250 mL, 0.75 gm/kg) was administered at ICP>25mmHg; pentobarbital coma was induced if ICP>25 mmHg while mannitol was administered. For Group 2, initial bolus of 20% mannitol (250 mL, 0.75 gm/kg) was given, followed by 0.25g m/kg boluses administered every 2 hr.

Outcome Measures: Mortality, Glasgow Outcome Scale (GOS), Intracranial Pressure (ICP).

1.        There was no significant difference in mortality between Groups 1 and 2 (35% versus 42.5%, p=0.26).

2.        There were no significant differences in GOS between groups.

3.        The proportion of patients achieving favourable outcome (GOS>4) in Group 1 was 54% and in Group 2 was 47.5%.

4.        Mean highest ICPs for survivors in Groups 1 and 2 were 35.2mmHg and 29.7mmHg, respectively, and for non-survivors were 46.2 mmHg and 40.7 mmHg, respectively.

5.        Mean highest ICP in all non-survivors was significantly higher (by approx. 11 mmHg) than that in all survivors (p=0.0002).

Scalfani et al. (2012)

USA

Pre-Post

N=8

Population: TBI; Mean Age=37.4 yr; Gender: Male=7, Female=1; Median Time Post Injury=3 days; Median GCS=7.

Intervention: Participants received 20% mannitol (n=6) or 23.4% saline (n=2) infused over 15 min.

Outcome Measures: Intracranial Pressure (ICP), Mean Arterial Pressure (MAP), Cerebral Perfusion Pressure (CPP).

1.        Results from patients who received saline and mannitol were not different and were combined for all analyses

2.        Treatment resulted in a significant reduction in ICP (22.4 mmHg to 15.7 mmHg, p<0.05).

3.        Treatment resulted in a significant elevation in CPP (75.7 mmHg to 81.9 mmHg, p<0.05).

4.        Treatment resulted in a stable MAP (103.3 mmHg versus 102.6 mmHg, p>0.05).

Sorani et al. (2008)

USA

Case Control

N=28

Population: TBI; Mean Age=39.3 yr; Gender: Male=24, Female=4; Median GCS=8.

Intervention: Patients treated with 100 g, 50 g, or both doses of mannitol were included in retrospective analysis.

Outcome Measure: Intracranial Pressure (ICP).

1.        Initial mean ICP was slightly higher in the 100 g group compared to the 50g group (23.9 mmHg versus 20.9 mmHg, p=0.14).

2.        By 100 min post treatment, mean ICP was significantly lower in the 100 g group compared tothe 50 g group (14.2 mmHg versus 18.6 mmHg, p=0.001).

3.        Over time, mean ICP decrease in the 50 g group was 3.6 mmHg, which was nearly two-fold lower than that of the 100 g group (8.8 mmHg).

4.        ICP response to mannitol was dose-dependent: every 7 g achieved an additional reduction of ~1.0 mmHg in ICP.