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Table 16.53 Miscellaneous Outcomes – Corticosteroids for Acute Management Post ABI

by | Dec 13, 2018

Table 16.53 Miscellaneous Outcomes – Corticosteroids for Acute Management Post ABI

 
Author/Year/ Country/ Study Design/N Methods Outcomes
Methylprednisolone
Roberts et al. (2004) International RCT PEDro=10 N=10,008 Population: ABI; Mean Age=37 yr; Gender: Male=6104, Female=1904; Median Time Post Injury=3 hr; Severity: Mild=3002, Moderate=3040, Severe=3966. Intervention: Patients were randomized to receive either methylprednisolone (n=5007) or placebo (n=5001). Methylprednisolone was administered intravenously at a loading dose of 2 g/hr in a 100 mL infusion, and maintained at 0.4 g/hr for 48 hr in a 20 mL/hr infusion. Outcomes were assessed at 2 wk post treatment. Outcome Measure: Mortality.
  1. Compared with the placebo group, the risk of death was higher in the methylprednisolone group (RR=1.18; p=0.0001).
  2. Relative risk of death did not differ by injury severity (p=0.22) or time post injury (p=0.05).
Giannotta et al. (1984) USA RCT PEDro=7 N=88 Population: TBI; Time Post Injury≤6 hr; GCS Range≤8. Intervention: Patients were randomized to receive high-dose methylprednisolone (n=38; 30 mg/kg/6 hr for 2 doses, 250 mg/6 hr for 8 doses, then tapered), low-dose methylprednisolone (n=34; 1.5mg/kg/6hr for 2 doses, 25 mg/6 hr for 8 doses, then tapered), or placebo (n=16) over 8 days. Outcome Measure: Glasgow Outcome Scale (GOS), Mortality.
  1. At 6mo, there was no significant difference in mortality or morbidity between groups.
  2. For patients younger than 40 yr, there was a combined 43% mortality in the low dose and placebo groups compared to a 6% mortality in the high dose group (p<0.05).
Saul et al. (1981) USA RCT PEDro=4 N=100 Population: TBI; Mean Age=31 yr; Time Post Injury≤6 hr; GCS Range≤7. Intervention: Patients were randomized receive to either intravenous methylprednisolone (250 mg bolus followed by a continuous 125 mg/6 hr infusion) or no drug. Outcome Measure: Glasgow Outcome Scale (GOS).
  1. At 6mo, no significant difference was seen in proportion of GOS=3-5 compared to GOSE=1-2 between groups (p=0.22).
Oliynyk et al. (2016) Ukraine & Poland Case Series N=267 Population: Severe TBI Intervention: Retrospective analysis of patients with sepsis and acute respiratory distress syndrome (ARDS) secondary to severe TBI who were administered Solu-Medrol (methylprednisolone) for 3 days (500 mg/ day), followed by reductions in dosage by one-half every 3 days after.  Patients were further analysed based on the type of respiratory support they received to treat their ARDS: controlled volume forced expiration, or biphasic positive airway pressure [BiPAP]). Outcome Measure: Mortality.
  1. Patient mortality decreased by 1.24x when BiPAP mechanical ventilation was used compared to volume-controlled forced ventilation (5-7mL/kg) (p=0.01). For the patients who survived, the duration of BiPAP ventilation was 1.32x shorter than forced ventilation with volume control duration.
  2. Corticosteroids improved mortality rate with both ventilation systems. For dead patients, corticosteroids prolonged ventilation time (all p<0.01) and for surviving patients, the ventilation period was shortened (both p<0.01).
Dexamethasone
Dearden et al. (1986) UK RCT PEDro=4 N=130 Population: TBI; Age Range=3-79 yr; Gender: Male=93, Female=37; Time Post Injury: ≤8 hr=93, >8 hr=37; Severity: Mild/Moderate=23, Severe=107. Intervention: Patients randomized to receive either IV bolus of dexamethasone (n=68) or placebo (n=62). Dexamethasone was administered intravenously at 100 mg/ days on days 1-3, 50 mg/ days on day 4, and 25 mg on day 5. Outcome Measure:  Glasgow Outcome Scale (GOS).
  1. GOS score at 6 mo was worse in the steroid group than the placebo group (49% versus 35.5% dead or vegetative), but the difference was not significant (p>0.05).
  2. Patients in the steroid group with ICP >20 mmHg and >30 mmHg showed significantly poorer outcomes on GOS compared to similar patients in the placebo group (p<0.05).
Braakman et al. (1983) Netherlands RCT PEDro=4 N=161 Population: TBI; Time Post Injury<6 hr; Severity: Severe. Intervention: Patients were randomized to receive either high-dose dexamethasone (n=81) or placebo (n=80). After a 100 mg intravenous (IV) dose, Dexamethasone was administered IV at 100 mg/ day from days 1-4, at 16 mg/ day IV or intramuscularly (IM) from days 5 to 7, and at 12 mg, 8 mg, 4 mg IV or IM on day 8 9, and 10, respectively. Outcome Measure: Glasgow Outcome Scale (GOS), Mortality.
  1. No significant differences were seen in 1mo mortality rates or in 6 mo GOS scores between groups.
Kaktis & Pitts et al. (1980) USA RCT PEDro=4 N=115 Population: ABI. Intervention: Patients were randomized to receive one of “mega dose” dexamethasone (50 mg, then 25 mg/ 6hr), conventional dose dexamethasone (10 mg, then 4 mg/6 hr) or saline placebo for a maximum of 7 days or until awakening. Outcome Measure: Infections of Cerebrospinal Fluid (CSF), Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH), Hyperglycemia.
  1. Infections of the cerebrospinal fluid was significantly higher in the mega dose group than conventional dose and placebo groups (8% versus 0% versus 0%, p<0.025).
  2. SIADH was significantly more prevalent in the conventional dose group than the mega dose and placebo groups (19% versus 10% versus 0%, p<0.05).
  3. Hyperglycemia was more prevalent in the mega and conventional dose groups than the placebo (35% versus 34% versus 11%, p=0.05).
Glucocorticoids
Watson et al. (2004) USA Cohort N=404 Population: TBI; Glucocorticoid (n=125): Mean Age=33 yr; Gender: Male=100, Female=25. Control (n=279): Mean Age=35 yr; Gender: Male=209, Female=70. Intervention: Patients treated with glucocorticoids were compared to those not receiving them (control). Outcome Measure: Incidence of Post-Traumatic Seizures (PTS).
  1. One hundred and five patients received glucocorticoids within 1 day of their injury, and 20 received them ≥2 days.
  2. Patients receiving glucocorticoids within 1 day were more likely to develop first late PTS than were those without (HR=1.74, p=0.04).
  3. Those receiving glucocorticoids ≥2 days post injury had no similar associations with PTS (HR=0.77, p=0.66).
  4. Glucocorticoid administration was not associated with second late PTS development in any group.
Triamcinolone
Grumme et al. (1995) Germany RCT PEDro=9 N=396 Population: TBI; Triamcinolone (n=187): Mean Age=31 yr; Gender: Male=154, Female=33. Placebo (n=209): Mean Age=31 yr; Gender: Male=168, Female=41. Intervention: Patients were randomized to receive either triamcinolone or placebo. Triamcinolone was administered intravenously at 200 mg within 4 hr of injury, followed by 3×40 mg/ day for 4 days and 3×20 mg/ day for 4days Outcome Measure: Glasgow Outcome Scale (GOS).
  1. No significant difference was observed between groups in GOS at discharge or at 1 yr follow-up.
  2. A significantly greater proportion of patients with GCS<8 and focal lesions treated with triamcinolone achieved good outcomes on GOS compared to those treated with placebo (16/46 versus 10/47, p=0.0145).
PEDro=Physiotherapy Evidence Database rating scale score (Moseley et al., 2002).